Friedreich Ataxia
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity. This study will also evaluate the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other secondary assessments.
Detailed description
The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat people who have Friedreich ataxia. This study will look at upper extremity (arms and hands) motor function and manual dexterity of people who take TAK-831. Efficacy evaluations also include other neurological, functional, and patient performance assessments. The study will enroll approximately 65 participants. Participants will be randomly assigned in a 2:1:2 ratio to one of the three treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-831 High dose * TAK-831 Low dose * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take three tablets of high dose, low dose, or placebo twice a day for 12 weeks. This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 13 weeks. Participants will make 5 visits to the clinic, and will be contacted by telephone for an exit interview no later than 7 days after their final visit or termination. Participants will also receive a safety follow-up phone call 7 to 17 days after receiving their last dose of TAK-831.
Interventions
DRUGTAK-831
TAK-831 tablets
DRUGTAK-831 Placebo
TAK-831 placebo matching tablets
Sponsors
Takeda
Neurocrine Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1\. Has a genetically-confirmed diagnosis (homozygous for guanine-adenine-adenine \[GAA\] repeat expansions in the frataxin gene \[FXN\] in the affected range of Friedreich ataxia \[FRDA\] or a compound heterozygous expansion with a point mutation or deletion), with an established disease stage of 2 to 5, inclusive, as determined by the Functional Staging for Ataxia, at Screening. Key
Exclusion criteria
1. Received a diagnosis of ataxic syndromes other than FRDA. 2. Has a history of cancer, except basal cell carcinoma or in situ cervical cancer that has been in remission for greater than or equal to (\>=5) years prior to first dose of study drug. 3. Known to be currently infected or has been infected with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus. 4. Has a known hypersensitivity to any component of the formulation of TAK-831. 5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse. 6. Has taken any excluded medication, or has had insufficient washout of medications or is unable or unwilling to discontinue medications as required by the protocol. 7. If male, the participant intends to donate sperm during the course of this study or for 95 days after the last dose of study drug. 8. If female, the participant is of childbearing potential and lactating, pregnant (positive prerandomization serum pregnancy test), or plans to become pregnant before participating in the study, during the study, or within 35 days after last dose of the study drug, or intending to donate ova during such time period. 9. Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1) | Baseline and Week 12 | The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Baseline and Weeks 2 and 7 | The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time, and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using MMRM ANCOVA with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions. |
| Change From Baseline in the ADL Component Individual Item Scores | Baseline and Weeks 2, 7 and 12 | The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently. A negative change from Baseline indicates improvement. Statistical analyses were available for the following subscales: cutting food-handling utensils, dressing and personal hygiene. |
| Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Baseline and Weeks 2, 7 and 12 | The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36 for a total possible score of 0 to 99 with higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by-visit interactions. |
| Change From Baseline in the mFARS-neuro Subscales Scores | Baseline and Weeks 2, 7, and 12 | The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36, with the higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by visit interactions. |
| Change From Baseline in the mFARS-neuro Individual Item Scores | Baseline and Weeks 2, 7, and 12 | mFARS-neuro examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia individual items:Cough,Speech,Right(R)Finger to Finger Test,Left(L)Finger to Finger Test,R-Nose to Finger Test,L-Nose to Finger Test,R-Dysmetria Test,L-Dysmetria Test,Rapid Alternating Movement(RAM)of R-Hands,RAM of L-Hands,R-Finger Taps(FT),L-FT,R-Heel Along Shin Slide,L-Heel Along Shin Slide,R-Heel Along Shin Tap,L-Heel Along Shin Tap,Siting Posture,Stance Feet Apart(SFA)-3 Trial Average(TTA),SFA(Eyes Closed)-TTA,Stance Feet Together(SFT)-TTA,SFT(Eyes Closed)-TTA,Tandem Stance-TTA,Stance on Dominant Foot-TTA,Tandem Walk and Gait.Items were scored on scale of 0 to 2,3,4 or 5,with higher scores indicating greater disability.Negative change from Baseline(BL)indicates improvement.Change from BL in mFARS-neuro was analyzed using MMRM ANCOVA with BL as covariate;pooled site,visit,treatment,ambulation status as fixed factors;treatment-by-visit,BL mFARS-neuro-by visit interactions. |
| Change From Baseline in the Timed 25-Foot Walk (T25FW) | Baseline and Weeks 2, 7 and 12 | The participant was instructed to walk 25 feet as quickly as possible, but safely. The time was calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task was immediately administered again by having the participant walk back the same distance. The two trials were averaged. A negative change from Baseline indicates improvement. Change from Baseline in T25FW was analyzed using MMRM ANCOVA with Baseline T25FW as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline T25FW-by-visit interactions. |
| Change From Baseline in the 9-HPT and T25FW Composite Score | Baseline and Weeks 2, 7, and 12 | 9-HPT and T25FW were evaluated together as a performance-based composite measure. The inverse transform of each score was computed. The inverse scores from each test were tabulated and converted to test-specific Z scores by subtracting the cohort mean from the raw score, and then dividing by the cohort standard deviation (SD) to create a Z score for the test. The composite Z scores were created by subtracting Z-score for T25FW from the Z-score for 9-HPT-1. A larger Z-score represents a better outcome. A positive change from Baseline indicates improvement. Change from Baseline in composite score was analyzed using MMRM ANCOVA with Baseline composite score as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline composite score-by-visit interactions. |
| Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Baseline and Weeks 2, 7, and, 12 | The LCLA test assessed visual function in both eyes using the Low-Contrast Sloan Letter Charts at different contrast levels. The score ranged from 0 to 70, where 0=worst visual functioning and 70=best visual functioning. A positive change from Baseline indicates improvement. The change from Baseline in LCLA was analyzed using MMRM ANCOVA with Baseline LCLA as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline LCLA-by-visit interactions. |
| Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Weeks 2, 7, and 12 | The clinician used the CGI-I scale to assess the participant's improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented. |
| Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Baseline and Weeks 2, 7 and 12 | The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 36, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in FARS ADL upper limb function items were analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions. |
| Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Weeks 2, 7, and 12 | The clinician used the CGI-I scale to assess the participant's improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented. |
| Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Weeks 2, 7, and 12 | The participant used the PGI-I scale to assess their improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented. |
| Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Baseline and Weeks 2, 7, and 12 | The clinician used the CGI-S scale to assess the severity of the participant's disease overall on a 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented. |
| Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Baseline and Weeks 2, 7, and 12 | The participant assessed the severity of their disease overall using the PGI-S 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented. |
| Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Baseline and Week 2, 7, and 12 | The clinician used the CGI-S scale to assess the severity of the participant's upper extremity function on a 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented. |
| Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Baseline and Weeks 2, 7, and 12 | The participant assessed the severity of their upper extremity function using the PGI-S 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented. |
| Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Baseline and Weeks 2, 7 and 12 | The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Items 3 to 5 are directly related to upper limb function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 12, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in Friedreich ataxia rating scale activities of daily living (FARS ADL) upper limb function items was analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions. |
| Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | Baseline up to Week 12 | The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time. |
| Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Weeks 2, 7 and 12 | The participant used the PGI-I scale to assess their improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 6 investigative sites in the United States from 08 November 2017 to 27 December 2018.
Pre-assignment details
Participants with a diagnosis of Friedreich Ataxia were randomized in a 2:1:2 ratio to receive TAK-831 75 mg TAK-831 300 mg or TAK-831 placebo-matching tablets twice daily.
Participants by arm
| Arm | Count |
|---|---|
| Placebo TAK-831 placebo-matching tablets, orally, twice daily for up to 12 weeks. | 27 |
| TAK-831 75 mg TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks. | 14 |
| TAK-831 300 mg TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks. | 26 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Reason Not Specified | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | TAK-831 300 mg | TAK-831 75 mg |
|---|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 11.01 | 31.1 years STANDARD_DEVIATION 10.23 | 29.6 years STANDARD_DEVIATION 8.92 | 31.1 years STANDARD_DEVIATION 11.28 |
| Average Inverse Time to Complete 9-hole peg test (9-HPT-1) First Assessment | 0.01740 1/seconds | 0.01680 1/seconds | 0.01575 1/seconds | 0.01660 1/seconds |
| Average Inverse Time to Complete 9-hole peg test (9-HPT-1) Second Assessment | 0.01710 1/seconds | 0.01660 1/seconds | 0.01595 1/seconds | 0.01605 1/seconds |
| Body Mass Index (BMI) | 24.89 kg/m^2 STANDARD_DEVIATION 4.92 | 24.18 kg/m^2 STANDARD_DEVIATION 4.456 | 23.02 kg/m^2 STANDARD_DEVIATION 3.862 | 24.94 kg/m^2 STANDARD_DEVIATION 4.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 27 Participants | 66 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Female | 17 Participants | 37 Participants | 15 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 30 Participants | 11 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 14 | 0 / 26 |
| other Total, other adverse events | 21 / 27 | 10 / 14 | 24 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 14 | 0 / 26 |
Outcome results
Primary
Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1)
The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.
Time frame: Baseline and Week 12
Population: Full analysis set (FAS) included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1) | 0.00038 1/seconds | Standard Error 0.000448 |
| TAK-831 75 mg | Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1) | -0.00017 1/seconds | Standard Error 0.000622 |
| TAK-831 300 mg | Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1) | -0.00032 1/seconds | Standard Error 0.000445 |
Comparison: Change from Baseline at Week 12p-value: >0.99990% CI: [-0.00179, 0.0007]ANCOVA
Comparison: Change from Baseline at Week 12p-value: >0.99990% CI: [-0.00172, 0.00033]ANCOVA
Secondary
Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score
The LCLA test assessed visual function in both eyes using the Low-Contrast Sloan Letter Charts at different contrast levels. The score ranged from 0 to 70, where 0=worst visual functioning and 70=best visual functioning. A positive change from Baseline indicates improvement. The change from Baseline in LCLA was analyzed using MMRM ANCOVA with Baseline LCLA as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline LCLA-by-visit interactions.
Time frame: Baseline and Weeks 2, 7, and, 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 7 | 4.6 score on a scale | Standard Error 2.2 |
| Placebo | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 2 | 1.8 score on a scale | Standard Error 2.56 |
| Placebo | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 12 | 0.0 score on a scale | Standard Error 2.61 |
| TAK-831 75 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 7 | -2.3 score on a scale | Standard Error 3.06 |
| TAK-831 75 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 2 | -0.9 score on a scale | Standard Error 3.61 |
| TAK-831 75 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 12 | -5.7 score on a scale | Standard Error 3.65 |
| TAK-831 300 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 2 | 5.1 score on a scale | Standard Error 2.53 |
| TAK-831 300 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 12 | 3.1 score on a scale | Standard Error 2.56 |
| TAK-831 300 mg | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Change from Baseline at Week 7 | 6.0 score on a scale | Standard Error 2.17 |
Comparison: Change from Baseline at Week 2p-value: 0.73590% CI: [-9.9, 4.4]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.18290% CI: [-2.7, 9.1]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.9790% CI: [-12.9, -0.9]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.32190% CI: [-3.6, 6.4]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.90590% CI: [-13, 1.5]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.19990% CI: [-2.9, 9]ANCOVA
Secondary
Change From Baseline in the 9-HPT and T25FW Composite Score
9-HPT and T25FW were evaluated together as a performance-based composite measure. The inverse transform of each score was computed. The inverse scores from each test were tabulated and converted to test-specific Z scores by subtracting the cohort mean from the raw score, and then dividing by the cohort standard deviation (SD) to create a Z score for the test. The composite Z scores were created by subtracting Z-score for T25FW from the Z-score for 9-HPT-1. A larger Z-score represents a better outcome. A positive change from Baseline indicates improvement. Change from Baseline in composite score was analyzed using MMRM ANCOVA with Baseline composite score as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline composite score-by-visit interactions.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 7 | -0.1112 z-score | Standard Error 0.24167 |
| Placebo | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 2 | 0.1369 z-score | Standard Error 0.21905 |
| Placebo | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 12 | 0.0060 z-score | Standard Error 0.22484 |
| TAK-831 75 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 7 | 0.0336 z-score | Standard Error 0.32731 |
| TAK-831 75 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 2 | 0.1819 z-score | Standard Error 0.28555 |
| TAK-831 75 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 12 | -0.2007 z-score | Standard Error 0.31057 |
| TAK-831 300 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 2 | -0.1911 z-score | Standard Error 0.24051 |
| TAK-831 300 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 12 | 0.1233 z-score | Standard Error 0.25501 |
| TAK-831 300 mg | Change From Baseline in the 9-HPT and T25FW Composite Score | Change from Baseline at Week 7 | -0.0998 z-score | Standard Error 0.26792 |
Comparison: Change from Baseline at Week 2p-value: 0.42690% CI: [-0.3665, 0.4565]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.97590% CI: [-0.6005, -0.0557]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.32490% CI: [-0.3931, 0.6826]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.48190% CI: [-0.3891, 0.4117]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.76590% CI: [-0.6911, 0.2778]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.2890% CI: [-0.2238, 0.4585]ANCOVA
Secondary
Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS)
The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 36, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in FARS ADL upper limb function items were analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Time frame: Baseline and Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 7 | -0.33 score on a scale | Standard Error 0.465 |
| Placebo | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 2 | -0.25 score on a scale | Standard Error 0.468 |
| Placebo | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 12 | -0.61 score on a scale | Standard Error 0.493 |
| TAK-831 75 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 7 | -0.15 score on a scale | Standard Error 0.655 |
| TAK-831 75 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 2 | -1.12 score on a scale | Standard Error 0.665 |
| TAK-831 75 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 12 | -0.37 score on a scale | Standard Error 0.696 |
| TAK-831 300 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 2 | 0.34 score on a scale | Standard Error 0.463 |
| TAK-831 300 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 12 | -0.24 score on a scale | Standard Error 0.488 |
| TAK-831 300 mg | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Change from Baseline at Week 7 | 0.03 score on a scale | Standard Error 0.467 |
Comparison: Change from Baseline at Week 2p-value: 0.13590% CI: [-2.18, 0.44]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.81890% CI: [-0.48, 1.66]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.59190% CI: [-1.11, 1.47]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.71390% CI: [-0.71, 1.44]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.61690% CI: [-1.13, 1.62]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.70890% CI: [-0.76, 1.51]ANCOVA
Secondary
Change From Baseline in the ADL Component Individual Item Scores
The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently. A negative change from Baseline indicates improvement. Statistical analyses were available for the following subscales: cutting food-handling utensils, dressing and personal hygiene.
Time frame: Baseline and Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Dressing | 0.00 score on a scale | Standard Deviation 0.392 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Bladder Function | -0.17 score on a scale | Standard Deviation 0.504 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Walking | -0.02 score on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Dressing | 0.04 score on a scale | Standard Deviation 0.372 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Speech | 0.07 score on a scale | Standard Deviation 0.494 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Falling | -0.29 score on a scale | Standard Deviation 0.932 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Dressing | 0.02 score on a scale | Standard Deviation 0.561 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Swallowing | 0.04 score on a scale | Standard Deviation 0.422 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Falling | -0.13 score on a scale | Standard Deviation 0.481 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Personal Hygiene | -0.02 score on a scale | Standard Deviation 0.427 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Bladder Function | -0.08 score on a scale | Standard Deviation 0.643 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Falling | 0.06 score on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Personal Hygiene | 0.08 score on a scale | Standard Deviation 0.659 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12,Quality of Sitting Position | 0.10 score on a scale | Standard Deviation 0.589 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Personal Hygiene | 0.08 score on a scale | Standard Deviation 0.602 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Swallowing | -0.15 score on a scale | Standard Deviation 0.403 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Speech | 0.06 score on a scale | Standard Deviation 0.425 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Quality of Sitting Position | 0.06 score on a scale | Standard Deviation 0.497 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Cutting-Handling Utensils | -0.13 score on a scale | Standard Deviation 0.451 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Speech | 0.06 score on a scale | Standard Deviation 0.516 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Quality of Sitting Position | 0.09 score on a scale | Standard Deviation 0.605 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Cutting-Handling Utensils | -0.21 score on a scale | Standard Deviation 0.619 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Bladder Function | -0.09 score on a scale | Standard Deviation 0.555 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Walking | 0.13 score on a scale | Standard Deviation 0.516 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Cutting-Handling Utensils | -0.19 score on a scale | Standard Deviation 0.548 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Swallowing | 0.00 score on a scale | Standard Deviation 0.555 |
| Placebo | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Walking | 0.00 score on a scale | Standard Deviation 0.245 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12,Quality of Sitting Position | -0.33 score on a scale | Standard Deviation 0.778 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Speech | -0.15 score on a scale | Standard Deviation 0.427 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Speech | -0.08 score on a scale | Standard Deviation 0.4 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Speech | -0.17 score on a scale | Standard Deviation 0.492 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Swallowing | 0.04 score on a scale | Standard Deviation 0.32 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Swallowing | 0.08 score on a scale | Standard Deviation 0.534 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Swallowing | 0.13 score on a scale | Standard Deviation 0.311 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Cutting-Handling Utensils | -0.04 score on a scale | Standard Deviation 0.38 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Cutting-Handling Utensils | -0.15 score on a scale | Standard Deviation 0.24 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Cutting-Handling Utensils | -0.08 score on a scale | Standard Deviation 0.417 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Dressing | -0.12 score on a scale | Standard Deviation 0.506 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Dressing | 0.04 score on a scale | Standard Deviation 0.38 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Dressing | -0.04 score on a scale | Standard Deviation 0.498 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Personal Hygiene | 0.00 score on a scale | Standard Deviation 0.456 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Personal Hygiene | 0.19 score on a scale | Standard Deviation 0.56 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Personal Hygiene | 0.21 score on a scale | Standard Deviation 0.656 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Falling | 0.04 score on a scale | Standard Deviation 0.66 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Falling | 0.54 score on a scale | Standard Deviation 1.266 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Falling | 0.50 score on a scale | Standard Deviation 0.739 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Walking | -0.08 score on a scale | Standard Deviation 0.494 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Walking | -0.08 score on a scale | Standard Deviation 0.344 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Walking | -0.08 score on a scale | Standard Deviation 0.557 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Quality of Sitting Position | -0.31 score on a scale | Standard Deviation 0.663 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Quality of Sitting Position | -0.27 score on a scale | Standard Deviation 0.753 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Bladder Function | -0.27 score on a scale | Standard Deviation 0.439 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Bladder Function | -0.15 score on a scale | Standard Deviation 0.555 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Bladder Function | -0.42 score on a scale | Standard Deviation 0.557 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Dressing | 0.12 score on a scale | Standard Deviation 0.516 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Speech | -0.06 score on a scale | Standard Deviation 0.432 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Walking | 0.08 score on a scale | Standard Deviation 0.272 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Cutting-Handling Utensils | 0.08 score on a scale | Standard Deviation 0.482 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Bladder Function | 0.13 score on a scale | Standard Deviation 0.46 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Walking | -0.06 score on a scale | Standard Deviation 0.45 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Cutting-Handling Utensils | 0.08 score on a scale | Standard Deviation 0.525 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Speech | -0.15 score on a scale | Standard Deviation 0.429 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Walking | 0.02 score on a scale | Standard Deviation 0.179 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Cutting-Handling Utensils | 0.12 score on a scale | Standard Deviation 0.535 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Bladder Function | -0.04 score on a scale | Standard Deviation 0.55 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Quality of Sitting Position | 0.10 score on a scale | Standard Deviation 0.375 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Swallowing | -0.27 score on a scale | Standard Deviation 0.589 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Bladder Function | 0.08 score on a scale | Standard Deviation 0.381 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Quality of Sitting Position | 0.00 score on a scale | Standard Deviation 0.511 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Personal Hygiene | 0.04 score on a scale | Standard Deviation 0.53 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Swallowing | -0.06 score on a scale | Standard Deviation 0.756 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Personal Hygiene | 0.06 score on a scale | Standard Deviation 0.517 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Personal Hygiene | 0.15 score on a scale | Standard Deviation 0.485 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Swallowing | -0.19 score on a scale | Standard Deviation 0.618 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 2, Falling | 0.02 score on a scale | Standard Deviation 0.435 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Dressing | -0.10 score on a scale | Standard Deviation 0.361 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12,Quality of Sitting Position | 0.08 score on a scale | Standard Deviation 0.458 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Falling | -0.04 score on a scale | Standard Deviation 0.706 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 7, Dressing | -0.04 score on a scale | Standard Deviation 0.292 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Speech | -0.02 score on a scale | Standard Deviation 0.403 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Individual Item Scores | Change at Week 12, Falling | -0.33 score on a scale | Standard Deviation 0.856 |
Comparison: Change at Week 2, Cutting-Handling Utensilsp-value: 0.57190% CI: [-0.23, 0.29]ANCOVA
Comparison: Change at Week 2, Cutting-Handling Utensilsp-value: 0.96390% CI: [0.02, 0.44]ANCOVA
Comparison: Change at Week 7, Cutting-Handling Utensilsp-value: 0.51590% CI: [-0.27, 0.28]ANCOVA
Comparison: Change at Week 7, Cutting-Handling Utensilsp-value: 0.98690% CI: [0.08, 0.54]ANCOVA
Comparison: Change at Week 12, Cutting-Handling Utensilsp-value: 0.71890% CI: [-0.18, 0.37]ANCOVA
Comparison: Change at Week 12, Cutting-Handling Utensilsp-value: 0.98690% CI: [0.08, 0.52]ANCOVA
Comparison: Change at Week 2, Dressingp-value: 0.15390% CI: [-0.4, 0.09]ANCOVA
Comparison: Change at Week 2, Dressingp-value: 0.86190% CI: [-0.07, 0.33]ANCOVA
Comparison: Change at Week 7, Dressingp-value: 0.44390% CI: [-0.22, 0.18]ANCOVA
Comparison: Change at Week 7, Dressingp-value: 0.35990% CI: [-0.2, 0.13]ANCOVA
Comparison: Change at Week 12, Dressingp-value: 0.26890% CI: [-0.36, 0.17]ANCOVA
Comparison: Change at Week 12, Dressingp-value: 0.41190% CI: [-0.24, 0.19]ANCOVA
Comparison: Change at Week 2, Personal Hygienep-value: 0.35890% CI: [-0.31, 0.2]ANCOVA
Comparison: Change at Week 2, Personal Hygienep-value: 0.94690% CI: [0, 0.41]ANCOVA
Comparison: Change at Week 7, Personal Hygienep-value: 0.50590% CI: [-0.32, 0.33]ANCOVA
Comparison: Change at Week 7, Personal Hygienep-value: 0.65890% CI: [-0.2, 0.33]ANCOVA
Comparison: Change at Week 12, Personal Hygienep-value: 0.64990% CI: [-0.24, 0.38]ANCOVA
Comparison: Change at Week 12, Personal Hygienep-value: 0.66190% CI: [-0.19, 0.32]ANCOVA
Secondary
Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS
The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Items 3 to 5 are directly related to upper limb function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 12, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in Friedreich ataxia rating scale activities of daily living (FARS ADL) upper limb function items was analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.
Time frame: Baseline and Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 7 | -0.17 score on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 2 | -0.21 score on a scale | Standard Error 0.213 |
| Placebo | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 12 | -0.15 score on a scale | Standard Error 0.24 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 7 | -0.14 score on a scale | Standard Error 0.289 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 2 | -0.40 score on a scale | Standard Error 0.308 |
| TAK-831 75 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 12 | -0.05 score on a scale | Standard Error 0.345 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 2 | 0.34 score on a scale | Standard Error 0.212 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 12 | 0.19 score on a scale | Standard Error 0.24 |
| TAK-831 300 mg | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Change from Baseline at Week 7 | 0.16 score on a scale | Standard Error 0.203 |
Comparison: Change from Baseline at Week 2p-value: 0.29990% CI: [-0.8, 0.41]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.96790% CI: [0.06, 1.04]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.52990% CI: [-0.54, 0.59]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.8890% CI: [-0.13, 0.8]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.59990% CI: [-0.58, 0.79]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.84690% CI: [-0.21, 0.9]ANCOVA
Secondary
Change From Baseline in the Inverse Time to Complete the 9-HPT-1
The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time, and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using MMRM ANCOVA with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.
Time frame: Baseline and Weeks 2 and 7
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 2 | 0.00087 1/seconds | Standard Error 0.000371 |
| Placebo | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 7 | 0.00040 1/seconds | Standard Error 0.000462 |
| TAK-831 75 mg | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 2 | 0.00048 1/seconds | Standard Error 0.000508 |
| TAK-831 75 mg | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 7 | 0.00026 1/seconds | Standard Error 0.000643 |
| TAK-831 300 mg | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 2 | -0.00006 1/seconds | Standard Error 0.00037 |
| TAK-831 300 mg | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Change from Baseline at Week 7 | -0.00004 1/seconds | Standard Error 0.000471 |
Comparison: Change from Baseline at Week 2p-value: 0.74190% CI: [-0.0014, 0.00062]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.96490% CI: [-0.00177, -0.00008]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.57390% CI: [-0.00143, 0.00115]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.74990% CI: [-0.00152, 0.00064]ANCOVA
Secondary
Change From Baseline in the mFARS-neuro Individual Item Scores
mFARS-neuro examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia individual items:Cough,Speech,Right(R)Finger to Finger Test,Left(L)Finger to Finger Test,R-Nose to Finger Test,L-Nose to Finger Test,R-Dysmetria Test,L-Dysmetria Test,Rapid Alternating Movement(RAM)of R-Hands,RAM of L-Hands,R-Finger Taps(FT),L-FT,R-Heel Along Shin Slide,L-Heel Along Shin Slide,R-Heel Along Shin Tap,L-Heel Along Shin Tap,Siting Posture,Stance Feet Apart(SFA)-3 Trial Average(TTA),SFA(Eyes Closed)-TTA,Stance Feet Together(SFT)-TTA,SFT(Eyes Closed)-TTA,Tandem Stance-TTA,Stance on Dominant Foot-TTA,Tandem Walk and Gait.Items were scored on scale of 0 to 2,3,4 or 5,with higher scores indicating greater disability.Negative change from Baseline(BL)indicates improvement.Change from BL in mFARS-neuro was analyzed using MMRM ANCOVA with BL as covariate;pooled site,visit,treatment,ambulation status as fixed factors;treatment-by-visit,BL mFARS-neuro-by visit interactions.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Nose to Finger Test (0-4) | 0.00 score on a scale | Standard Error 0.098 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA (Eyes Closed) - TTA (0-4) | 0.2 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Slide (0-4) | 0.01 score on a scale | Standard Error 0.121 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Nose to Finger Test (0-4) | -0.05 score on a scale | Standard Error 0.096 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Gait (0-5) | -0.1 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Heel Along Shin Slide(0-4) | -0.43 score on a scale | Standard Error 0.164 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Nose to Finger Test (0-4) | 0.15 score on a scale | Standard Error 0.095 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Stance - TTA (0-4) | 0.0 score on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Heel Along Shin Slide(0-4) | -0.18 score on a scale | Standard Error 0.152 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Nose to Finger Test (0-4) | 0.11 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Stance - TTA (0-4) | 0.0 score on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Heel Along Shin Slide(0-4) | -0.24 score on a scale | Standard Error 0.118 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Dysmetria Test (0-4) | -0.11 score on a scale | Standard Error 0.106 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Gait (0-5) | -0.1 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Finger Taps (0-4) | -0.50 score on a scale | Standard Error 0.161 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Dysmetria Test (0-4) | -0.23 score on a scale | Standard Error 0.129 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger Taps (0-4) | -0.37 score on a scale | Standard Error 0.131 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Dysmetria Test (0-4) | -0.11 score on a scale | Standard Error 0.132 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger Taps (0-4) | -0.22 score on a scale | Standard Error 0.132 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Dysmetria Test (0-4) | -0.27 score on a scale | Standard Error 0.111 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Cough (0-2) | 0.06 score on a scale | Standard Error 0.051 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Finger Taps (0-4) | -0.31 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Dysmetria Test (0-4) | -0.02 score on a scale | Standard Error 0.136 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Finger Taps (0-4) | -0.18 score on a scale | Standard Error 0.136 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Dysmetria Test (0-4) | -0.17 score on a scale | Standard Error 0.151 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA - TTA (0-4) | -0.1 score on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Finger Taps (0-4) | -0.39 score on a scale | Standard Error 0.121 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Right Hands (0-3) | -0.18 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Cough (0-2) | 0.01 score on a scale | Standard Error 0.063 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Left Hands (0-3) | -0.20 score on a scale | Standard Error 0.096 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Right Hands (0-3) | 0.03 score on a scale | Standard Error 0.122 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Left Hands (0-3) | -0.08 score on a scale | Standard Error 0.123 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Right Hands (0-3) | -0.07 score on a scale | Standard Error 0.113 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA - TTA (0-4) | 0.1 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Left Hands (0-3) | -0.11 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Cough (0-2) | 0.01 score on a scale | Standard Error 0.063 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT - TTA (0-4) | 0.0 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA -TTA (0-4) | -0.1 score on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Speech (0-3) | 0.00 score on a scale | Standard Error 0.058 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Siting Posture (0-4) | -0.1 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Speech (0-3) | 0.00 score on a scale | Standard Error 0.043 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Siting Posture (0-4) | -0.4 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Speech (0-3) | 0.00 score on a scale | Standard Error 0.056 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT - TTA (0-4) | -0.1 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Siting Posture (0-4) | -0.3 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Finger to Finger Test(0-3) | 0.10 score on a scale | Standard Error 0.079 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Heel Along Shin Tap (0-4) | -0.52 score on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Finger to Finger Test(0-3) | 0.04 score on a scale | Standard Error 0.075 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Stance - TTA (0-4) | 0.1 score on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Tap (0-4) | -0.36 score on a scale | Standard Error 0.165 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Finger to Finger Test(0-3) | 0.21 score on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT - TTA (0-4) | 0.0 score on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Tap (0-4) | -0.38 score on a scale | Standard Error 0.121 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger to Finger Test (0-3) | 0.04 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Heel Along Shin Tap (0-4) | -0.32 score on a scale | Standard Error 0.137 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger to Finger Test (0-3) | 0.05 score on a scale | Standard Error 0.075 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Heel Along Shin Tap (0-4) | -0.14 score on a scale | Standard Error 0.163 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Finger to Finger Test(0-3) | 0.13 score on a scale | Standard Error 0.095 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA (Eyes Closed) - TTA (0-4) | 0.2 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Heel Along Shin Tap (0-4) | -0.39 score on a scale | Standard Error 0.114 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Nose to Finger Test (0-4) | -0.08 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Gait (0-5) | -0.3 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Heel Along Shin Slide(0-4) | -0.16 score on a scale | Standard Error 0.151 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Nose to Finger Test (0-4) | 0.01 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| Placebo | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Slide (0-4) | 0.08 score on a scale | Standard Error 0.133 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.1 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Stance - TTA (0-4) | -0.1 score on a scale | Standard Error 0.07 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Stance - TTA (0-4) | 0.0 score on a scale | Standard Error 0.07 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.07 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Walk (0-3) | -0.1 score on a scale | Standard Error 0.07 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Walk (0-3) | -0.1 score on a scale | Standard Error 0.08 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Gait (0-5) | -0.2 score on a scale | Standard Error 0.17 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Gait (0-5) | -0.3 score on a scale | Standard Error 0.15 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Gait (0-5) | -0.2 score on a scale | Standard Error 0.15 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Cough (0-2) | 0.07 score on a scale | Standard Error 0.072 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Cough (0-2) | -0.05 score on a scale | Standard Error 0.087 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Cough (0-2) | 0.08 score on a scale | Standard Error 0.088 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Speech (0-3) | 0.08 score on a scale | Standard Error 0.083 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Speech (0-3) | -0.04 score on a scale | Standard Error 0.06 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Speech (0-3) | 0.00 score on a scale | Standard Error 0.079 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Finger to Finger Test(0-3) | 0.17 score on a scale | Standard Error 0.109 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Finger to Finger Test(0-3) | 0.12 score on a scale | Standard Error 0.102 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Finger to Finger Test(0-3) | 0.12 score on a scale | Standard Error 0.105 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger to Finger Test (0-3) | 0.13 score on a scale | Standard Error 0.12 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger to Finger Test (0-3) | 0.07 score on a scale | Standard Error 0.104 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Finger to Finger Test(0-3) | 0.22 score on a scale | Standard Error 0.132 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Nose to Finger Test (0-4) | 0.21 score on a scale | Standard Error 0.126 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Nose to Finger Test (0-4) | 0.09 score on a scale | Standard Error 0.147 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Nose to Finger Test (0-4) | -0.15 score on a scale | Standard Error 0.14 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Nose to Finger Test (0-4) | 0.08 score on a scale | Standard Error 0.137 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Nose to Finger Test (0-4) | 0.32 score on a scale | Standard Error 0.133 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Nose to Finger Test (0-4) | 0.10 score on a scale | Standard Error 0.141 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Dysmetria Test (0-4) | -0.15 score on a scale | Standard Error 0.151 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Dysmetria Test (0-4) | -0.11 score on a scale | Standard Error 0.181 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Dysmetria Test (0-4) | 0.01 score on a scale | Standard Error 0.185 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Dysmetria Test (0-4) | 0.02 score on a scale | Standard Error 0.16 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Dysmetria Test (0-4) | -0.26 score on a scale | Standard Error 0.191 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Dysmetria Test (0-4) | -0.11 score on a scale | Standard Error 0.211 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Right Hands (0-3) | 0.05 score on a scale | Standard Error 0.145 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Right Hands (0-3) | -0.03 score on a scale | Standard Error 0.17 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Right Hands (0-3) | 0.12 score on a scale | Standard Error 0.156 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Left Hands (0-3) | -0.03 score on a scale | Standard Error 0.12 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Left Hands (0-3) | 0.01 score on a scale | Standard Error 0.173 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Left Hands (0-3) | 0.11 score on a scale | Standard Error 0.133 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Finger Taps (0-4) | 0.05 score on a scale | Standard Error 0.172 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Finger Taps (0-4) | 0.04 score on a scale | Standard Error 0.19 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Finger Taps (0-4) | -0.13 score on a scale | Standard Error 0.195 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger Taps (0-4) | 0.28 score on a scale | Standard Error 0.189 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger Taps (0-4) | 0.22 score on a scale | Standard Error 0.182 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Finger Taps (0-4) | 0.07 score on a scale | Standard Error 0.225 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Heel Along Shin Slide(0-4) | -0.04 score on a scale | Standard Error 0.166 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Heel Along Shin Slide(0-4) | -0.32 score on a scale | Standard Error 0.209 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Heel Along Shin Slide(0-4) | -0.09 score on a scale | Standard Error 0.223 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Slide (0-4) | -0.15 score on a scale | Standard Error 0.174 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Slide (0-4) | -0.23 score on a scale | Standard Error 0.187 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Heel Along Shin Slide(0-4) | -0.18 score on a scale | Standard Error 0.21 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Heel Along Shin Tap (0-4) | -0.17 score on a scale | Standard Error 0.159 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Heel Along Shin Tap (0-4) | -0.41 score on a scale | Standard Error 0.224 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Heel Along Shin Tap (0-4) | -0.18 score on a scale | Standard Error 0.184 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Tap (0-4) | -0.22 score on a scale | Standard Error 0.171 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Tap (0-4) | 0.01 score on a scale | Standard Error 0.23 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Heel Along Shin Tap (0-4) | -0.21 score on a scale | Standard Error 0.251 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Siting Posture (0-4) | -0.1 score on a scale | Standard Error 0.15 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Siting Posture (0-4) | -0.5 score on a scale | Standard Error 0.15 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Siting Posture (0-4) | -0.3 score on a scale | Standard Error 0.16 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA -TTA (0-4) | 0.0 score on a scale | Standard Error 0.21 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA - TTA (0-4) | 0.0 score on a scale | Standard Error 0.17 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA - TTA (0-4) | 0.0 score on a scale | Standard Error 0.19 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.16 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA (Eyes Closed) - TTA (0-4) | 0.2 score on a scale | Standard Error 0.19 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT - TTA (0-4) | -0.3 score on a scale | Standard Error 0.26 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT - TTA (0-4) | -0.1 score on a scale | Standard Error 0.15 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT - TTA (0-4) | -0.2 score on a scale | Standard Error 0.19 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.09 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.09 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.09 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Stance - TTA (0-4) | 0.0 score on a scale | Standard Error 0.07 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Nose to Finger Test (0-4) | 0.00 score on a scale | Standard Error 0.097 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.06 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Slide (0-4) | 0.05 score on a scale | Standard Error 0.121 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Nose to Finger Test (0-4) | -0.07 score on a scale | Standard Error 0.107 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Stance - TTA (0-4) | 0.1 score on a scale | Standard Error 0.05 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Slide (0-4) | -0.09 score on a scale | Standard Error 0.138 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Nose to Finger Test (0-4) | 0.06 score on a scale | Standard Error 0.085 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.14 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Heel Along Shin Slide(0-4) | -0.15 score on a scale | Standard Error 0.149 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Left Finger to Finger Test(0-3) | 0.04 score on a scale | Standard Error 0.093 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.05 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Heel Along Shin Tap (0-4) | 0.04 score on a scale | Standard Error 0.113 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger to Finger Test (0-3) | 0.07 score on a scale | Standard Error 0.077 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT (Eyes Closed) - TTA (0-4) | 0.1 score on a scale | Standard Error 0.07 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Heel Along Shin Tap (0-4) | -0.14 score on a scale | Standard Error 0.168 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger to Finger Test (0-3) | 0.07 score on a scale | Standard Error 0.084 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT - TTA (0-4) | 0.4 score on a scale | Standard Error 0.19 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Heel Along Shin Tap (0-4) | 0.01 score on a scale | Standard Error 0.131 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Finger to Finger Test(0-3) | 0.06 score on a scale | Standard Error 0.074 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Walk (0-3) | 0.0 score on a scale | Standard Error 0.05 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Heel Along Shin Tap (0-4) | -0.05 score on a scale | Standard Error 0.12 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Finger to Finger Test(0-3) | -0.02 score on a scale | Standard Error 0.075 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Tandem Stance - TTA (0-4) | 0.1 score on a scale | Standard Error 0.05 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Heel Along Shin Tap (0-4) | -0.15 score on a scale | Standard Error 0.171 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Finger to Finger Test(0-3) | 0.06 score on a scale | Standard Error 0.078 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFT - TTA (0-4) | 0.3 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Heel Along Shin Tap (0-4) | -0.27 score on a scale | Standard Error 0.178 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Speech (0-3) | 0.09 score on a scale | Standard Error 0.057 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Siting Posture (0-4) | -0.1 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Speech (0-3) | 0.07 score on a scale | Standard Error 0.045 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Tandem Stance - TTA (0-4) | 0.0 score on a scale | Standard Error 0.05 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Siting Posture (0-4) | -0.2 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Speech (0-3) | 0.10 score on a scale | Standard Error 0.06 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT - TTA (0-4) | 0.3 score on a scale | Standard Error 0.14 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Siting Posture (0-4) | -0.1 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Cough (0-2) | 0.13 score on a scale | Standard Error 0.063 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA -TTA (0-4) | -0.1 score on a scale | Standard Error 0.15 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Right Hands (0-3) | -0.12 score on a scale | Standard Error 0.112 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Cough (0-2) | 0.11 score on a scale | Standard Error 0.065 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Left Hands (0-3) | -0.03 score on a scale | Standard Error 0.085 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Right Hands (0-3) | 0.03 score on a scale | Standard Error 0.126 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFT (Eyes Closed) - TTA (0-4) | -0.1 score on a scale | Standard Error 0.06 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, RAM of Left Hands (0-3) | 0.05 score on a scale | Standard Error 0.129 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, RAM of Right Hands (0-3) | -0.06 score on a scale | Standard Error 0.102 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA - TTA (0-4) | -0.1 score on a scale | Standard Error 0.12 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, RAM of Left Hands (0-3) | 0.02 score on a scale | Standard Error 0.095 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Dysmetria Test (0-4) | 0.06 score on a scale | Standard Error 0.149 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Cough (0-2) | 0.06 score on a scale | Standard Error 0.051 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Finger Taps (0-4) | -0.23 score on a scale | Standard Error 0.124 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Dysmetria Test (0-4) | -0.16 score on a scale | Standard Error 0.141 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFT (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.06 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Finger Taps (0-4) | -0.19 score on a scale | Standard Error 0.143 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Dysmetria Test (0-4) | -0.12 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, SFA - TTA (0-4) | 0.0 score on a scale | Standard Error 0.13 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Finger Taps (0-4) | -0.37 score on a scale | Standard Error 0.14 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Right Dysmetria Test (0-4) | -0.16 score on a scale | Standard Error 0.13 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Gait (0-5) | 0.1 score on a scale | Standard Error 0.1 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Finger Taps (0-4) | -0.17 score on a scale | Standard Error 0.132 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Right Dysmetria Test (0-4) | -0.06 score on a scale | Standard Error 0.134 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Gait (0-5) | 0.2 score on a scale | Standard Error 0.11 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Finger Taps (0-4) | -0.21 score on a scale | Standard Error 0.136 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Right Dysmetria Test (0-4) | 0.01 score on a scale | Standard Error 0.105 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, SFA (Eyes Closed) - TTA (0-4) | -0.1 score on a scale | Standard Error 0.07 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Finger Taps (0-4) | -0.17 score on a scale | Standard Error 0.16 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12, Left Nose to Finger Test (0-4) | 0.14 score on a scale | Standard Error 0.099 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Gait (0-5) | 0.2 score on a scale | Standard Error 0.12 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Right Heel Along Shin Slide(0-4) | -0.24 score on a scale | Standard Error 0.117 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, Left Nose to Finger Test (0-4) | 0.01 score on a scale | Standard Error 0.098 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2,Stance on Dominant Foot-TTA(0-4) | NA score on a scale | — |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7,Right Heel Along Shin Slide(0-4) | -0.35 score on a scale | Standard Error 0.155 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 2, Left Nose to Finger Test (0-4) | 0.05 score on a scale | Standard Error 0.095 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 7, SFA (Eyes Closed) - TTA (0-4) | 0.0 score on a scale | Standard Error 0.12 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Individual Item Scores | Change at Week 12,Right Heel Along Shin Slide(0-4) | -0.30 score on a scale | Standard Error 0.16 |
Comparison: Change at Week 2, Cough90% CI: [-0.13, 0.15]
Comparison: Change at Week 2, Cough90% CI: [-0.11, 0.12]
Comparison: Change at Week 7, Cough90% CI: [-0.24, 0.11]
Comparison: Change at Week 7, Cough90% CI: [-0.05, 0.25]
Comparison: Change at Week 12, Cough90% CI: [-0.11, 0.25]
Comparison: Change at Week 12, Cough90% CI: [-0.03, 0.26]
Comparison: Change at Week 2, Speech90% CI: [-0.09, 0.25]
Comparison: Change at Week 2, Speech90% CI: [-0.04, 0.24]
Comparison: Change at Week 7, Speech90% CI: [-0.16, 0.08]
Comparison: Change at Week 7, Speech90% CI: [-0.03, 0.17]
Comparison: Change at Week 12, Speech90% CI: [-0.16, 0.16]
Comparison: Change at Week 12, Speech90% CI: [-0.04, 0.22]
Comparison: Change at Week 2, Right Finger to Finger Test90% CI: [-0.14, 0.29]
Comparison: Change at Week 2, Right Finger to Finger Test90% CI: [-0.22, 0.14]
Comparison: Change at Week 7, Right Finger to Finger Test90% CI: [-0.13, 0.28]
Comparison: Change at Week 7, Right Finger to Finger Test90% CI: [-0.24, 0.11]
Comparison: Change at Week 12, Right Finger to Finger Test90% CI: [-0.3, 0.12]
Comparison: Change at Week 12, Right Finger to Finger Test90% CI: [-0.32, 0.03]
Comparison: Change at Week 2, Left Finger to Finger Test90% CI: [-0.15, 0.33]
Comparison: Change at Week 2, Left Finger to Finger Test90% CI: [-0.16, 0.23]
Comparison: Change at Week 7, Left Finger to Finger Test90% CI: [-0.18, 0.23]
Comparison: Change at Week 7, Left Finger to Finger Test90% CI: [-0.15, 0.2]
Comparison: Change at Week 12, Left Finger to Finger Test90% CI: [-0.17, 0.36]
Comparison: Change at Week 12, Left Finger to Finger Test90% CI: [-0.3, 0.13]
Comparison: Change at Week 2, Right Nose to Finger Test90% CI: [0.04, 0.53]
Comparison: Change at Week 2, Right Nose to Finger Test90% CI: [-0.06, 0.33]
Comparison: Change at Week 7, Right Nose to Finger Test90% CI: [-0.22, 0.37]
Comparison: Change at Week 7, Right Nose to Finger Test90% CI: [-0.32, 0.16]
Comparison: Change at Week 12, Right Nose to Finger Test90% CI: [-0.43, 0.12]
Comparison: Change at Week 12, Right Nose to Finger Test90% CI: [-0.23, 0.23]
Comparison: Change at Week 2, Left Nose to Finger Test90% CI: [-0.14, 0.4]
Comparison: Change at Week 2, Left Nose to Finger Test90% CI: [-0.12, 0.33]
Comparison: Change at Week 7, Left Nose to Finger Test90% CI: [-0.09, 0.43]
Comparison: Change at Week 7, Left Nose to Finger Test90% CI: [-0.36, 0.09]
Comparison: Change at Week 12, Left Nose to Finger Test90% CI: [-0.29, 0.27]
Comparison: Change at Week 12, Left Nose to Finger Test90% CI: [-0.21, 0.27]
Comparison: Change at Week 2, Right Dysmetria Test90% CI: [-0.33, 0.26]
Comparison: Change at Week 2, Right Dysmetria Test90% CI: [-0.12, 0.36]
Comparison: Change at Week 7, Right Dysmetria Test90% CI: [-0.25, 0.48]
Comparison: Change at Week 7, Right Dysmetria Test90% CI: [-0.14, 0.47]
Comparison: Change at Week 12, Right Dysmetria Test90% CI: [-0.26, 0.48]
Comparison: Change at Week 12, Right Dysmetria Test90% CI: [-0.36, 0.25]
Comparison: Change at Week 2, Left Dysmetria Test90% CI: [-0.02, 0.6]
Comparison: Change at Week 2, Left Dysmetria Test90% CI: [-0.1, 0.41]
Comparison: Change at Week 7, Left Dysmetria Test90% CI: [-0.63, 0.13]
Comparison: Change at Week 7, Left Dysmetria Test90% CI: [-0.47, 0.18]
Comparison: Change at Week 12, Left Dysmetria Test90% CI: [-0.37, 0.48]
Comparison: Change at Week 12, Left Dysmetria Test90% CI: [-0.11, 0.58]
Comparison: Change at Week 2, RAM of Right Hands90% CI: [-0.06, 0.51]
Comparison: Change at Week 2, RAM of Right Hands90% CI: [-0.12, 0.35]
Comparison: Change at Week 7, RAM of Right Hands90% CI: [-0.41, 0.28]
Comparison: Change at Week 7, RAM of Right Hands90% CI: [-0.29, 0.29]
Comparison: Change at Week 12, RAM of Right Hands90% CI: [-0.12, 0.51]
Comparison: Change at Week 12, RAM of Right Hands90% CI: [-0.31, 0.21]
Comparison: Change at Week 2, RAM of Left Hands90% CI: [-0.15, 0.32]
Comparison: Change at Week 2, RAM of Left Hands90% CI: [-0.12, 0.27]
Comparison: Change at Week 7, RAM of Left Hands90% CI: [-0.27, 0.43]
Comparison: Change at Week 7, RAM of Left Hands90% CI: [-0.17, 0.42]
Comparison: Change at Week 12, RAM of Left Hand90% CI: [0.04, 0.58]
Comparison: Change at Week 12, RAM of Left Hand90% CI: [-0.01, 0.43]
Comparison: Change at Week 2, Right Finger Taps90% CI: [0.1, 0.77]
Comparison: Change at Week 2, Right Finger Taps90% CI: [-0.12, 0.44]
Comparison: Change at Week 7, Right Finger Taps90% CI: [-0.16, 0.6]
Comparison: Change at Week 7, Right Finger Taps90% CI: [-0.33, 0.31]
Comparison: Change at Week 12, Right Finger Taps90% CI: [-0.22, 0.56]
Comparison: Change at Week 12, Right Finger Taps90% CI: [-0.39, 0.26]
Comparison: Change at Week 2, Left Finger Taps90% CI: [0.12, 0.87]
Comparison: Change at Week 2, Left Finger Taps90% CI: [-0.25, 0.36]
Comparison: Change at Week 7, Left Finger Taps90% CI: [0.22, 0.95]
Comparison: Change at Week 7, Left Finger Taps90% CI: [-0.15, 0.47]
Comparison: Change at Week 12, Left Finger Taps90% CI: [0.11, 1.02]
Comparison: Change at Week 12, Left Finger Taps90% CI: [-0.04, 0.71]
Comparison: Change at Week 2, Right Heel Along Shin Slide90% CI: [-0.12, 0.53]
Comparison: Change at Week 2, Right Heel Along Shin Slide90% CI: [-0.26, 0.27]
Comparison: Change at Week 7, Right Heel Along Shin Slide90% CI: [-0.56, 0.28]
Comparison: Change at Week 7, Right Heel Along Shin Slide90% CI: [-0.53, 0.19]
Comparison: Change at Week 12,Right Heel Along Shin Slide90% CI: [-0.12, 0.78]
Comparison: Change at Week 12,Right Heel Along Shin Slide90% CI: [-0.25, 0.51]
Comparison: Change at Week 2, Left Heel Along Shin Slide90% CI: [-0.51, 0.18]
Comparison: Change at Week 2, Left Heel Along Shin Slide90% CI: [-0.25, 0.31]
Comparison: Change at Week 7, Left Heel Along Shin Slide90% CI: [-0.68, 0.07]
Comparison: Change at Week 7, Left Heel Along Shin Slide90% CI: [-0.48, 0.15]
Comparison: Change at Week 12, Left Heel Along Shin Slide90% CI: [-0.45, 0.4]
Comparison: Change at Week 12, Left Heel Along Shin Slide90% CI: [-0.34, 0.36]
Comparison: Change at Week 2, Right Heel Along Shin Tap90% CI: [-0.1, 0.53]
Comparison: Change at Week 2, Right Heel Along Shin Tap90% CI: [0.17, 0.69]
Comparison: Change at Week 7, Right Heel Along Shin Tap90% CI: [-0.72, 0.19]
Comparison: Change at Week 7, Right Heel Along Shin Tap90% CI: [-0.38, 0.39]
Comparison: Change at Week 12, Right Heel Along Shin Tap90% CI: [-0.23, 0.51]
Comparison: Change at Week 7, SFA - TTA90% CI: [-0.4, 0.2]
Comparison: Change at Week 12, Right Heel Along Shin Tap90% CI: [0.02, 0.64]
Comparison: Change at Week 2, Left Heel Along Shin Tap90% CI: [-0.17, 0.5]
Comparison: Change at Week 2, Left Heel Along Shin Tap90% CI: [0.06, 0.61]
Comparison: Change at Week 7, Left Heel Along Shin Tap90% CI: [-0.09, 0.84]
Comparison: Change at Week 7, Left Heel Along Shin Tap90% CI: [-0.19, 0.6]
Comparison: Change at Week 12, Left Heel Along Shin Tap90% CI: [-0.2, 0.82]
Comparison: Change at Week 12, Left Heel Along Shin Tap90% CI: [-0.17, 0.67]
Comparison: Change at Week 2, Siting Posture90% CI: [-0.1, 0.5]
Comparison: Change at Week 2, Siting Posture90% CI: [-0.1, 0.4]
Comparison: Change at Week 7, Siting Posture90% CI: [-0.4, 0.2]
Comparison: Change at Week 7, Siting Posture90% CI: [0, 0.5]
Comparison: Change at Week 12, Siting Posture90% CI: [-0.5, 0.2]
Comparison: Change at Week 12, Siting Posture90% CI: [-0.2, 0.3]
Comparison: Change at Week 2, SFA - TTA90% CI: [-0.4, 0.4]
Comparison: Change at Week 2, SFA - TTA90% CI: [-0.3, 0.3]
Comparison: Change at Week 7, SFA - TTA90% CI: [-0.5, 0.1]
Comparison: Change at Week 12, SFA - TTA90% CI: [-0.3, 0.4]
Comparison: Change at Week 12, SFA - TTA90% CI: [-0.2, 0.4]
Comparison: Change at Week 2, SFA (Eyes Closed) - TTA90% CI: [-0.1, 0.3]
Comparison: Change at Week 2, SFA (Eyes Closed) - TTA90% CI: [-0.2, 0.1]
Comparison: Change at Week 7, SFA (Eyes Closed) - TTA90% CI: [-0.4, 0.2]
Comparison: Change at Week 7, SFA (Eyes Closed) - TTA90% CI: [-0.4, 0.1]
Comparison: Change at Week 12, SFA (Eyes Closed) - TTA90% CI: [-0.3, 0.4]
Comparison: Change at Week 12, SFA (Eyes Closed) - TTA90% CI: [-0.5, 0.1]
Comparison: Change at Week 2, SFT - TTA90% CI: [-0.8, 0.2]
Comparison: Change at Week 2, SFT - TTA90% CI: [0, 0.8]
Comparison: Change at Week 7, SFT - TTA90% CI: [-0.3, 0.4]
Comparison: Change at Week 7, SFT - TTA90% CI: [0.2, 0.7]
Comparison: Change at Week 12, SFT - TTA90% CI: [-0.5, 0.2]
Comparison: Change at Week 12, SFT - TTA90% CI: [0, 0.7]
Comparison: Change at Week 2, SFT (Eyes Closed) - TTA90% CI: [-0.2, 0.1]
Comparison: Change at Week 2, SFT (Eyes Closed) - TTA90% CI: [-0.2, 0.1]
Comparison: Change at Week 7, SFT (Eyes Closed) - TTA90% CI: [-0.2, 0.2]
Comparison: Change at Week 7, SFT (Eyes Closed) - TTA90% CI: [-0.1, 0.2]
Comparison: Change at Week 12, SFT (Eyes Closed) - TTA90% CI: [-0.2, 0.2]
Comparison: Change at Week 12, SFT (Eyes Closed) - TTA90% CI: [-0.3, 0]
Comparison: Change at Week 2, Tandem Stance - TTA90% CI: [-0.2, 0.1]
Comparison: Change at Week 2, Tandem Stance - TTA90% CI: [-0.1, 0.1]
Comparison: Change at Week 7, Tandem Stance - TTA90% CI: [-0.2, 0]
Comparison: Change at Week 7, Tandem Stance - TTA90% CI: [-0.1, 0.2]
Comparison: Change at Week 12, Tandem Stance - TTA90% CI: [-0.2, 0.1]
Comparison: Change at Week 12, Tandem Stance - TTA90% CI: [-0.1, 0.2]
Comparison: Change at Week 2, Tandem Walk90% CI: [-0.1, 0.1]
Comparison: Change at Week 2, Tandem Walk90% CI: [-0.1, 0.1]
Comparison: Change at Week 7, Tandem Walk90% CI: [-0.2, 0.1]
Comparison: Change at Week 7, Tandem Walk90% CI: [-0.1, 0.1]
Comparison: Change at Week 12, Tandem Walk90% CI: [-0.3, 0]
Comparison: Change at Week 12, Tandem Walk90% CI: [-0.2, 0.1]
Comparison: Change at Week 2, Gait90% CI: [-0.2, 0.4]
Comparison: Change at Week 2, Gait90% CI: [0.1, 0.7]
Comparison: Change at Week 7, Gait90% CI: [-0.4, 0.2]
Comparison: Change at Week 7, Gait90% CI: [0.1, 0.6]
Comparison: Change at Week 12, Gait90% CI: [-0.4, 0.2]
Comparison: Change at Week 12, Gait90% CI: [0, 0.5]
Secondary
Change From Baseline in the mFARS-neuro Subscales Scores
The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36, with the higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by visit interactions.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Bulbar | 0.08 unit on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Bulbar | 0.01 unit on a scale | Standard Error 0.074 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Bulbar | 0.01 unit on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upper Limb Coordination | -1.55 unit on a scale | Standard Error 0.425 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upper Limb Coordination | -0.90 unit on a scale | Standard Error 0.533 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upper Limb Coordination | -1.19 unit on a scale | Standard Error 0.608 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Lower Limb Coordination | -0.92 unit on a scale | Standard Error 0.292 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Lower Limb Coordination | -0.84 unit on a scale | Standard Error 0.494 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Lower Limb Coordination | -1.62 unit on a scale | Standard Error 0.449 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upright Stability | -0.5 unit on a scale | Standard Error 0.37 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upright Stability | -0.2 unit on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upright Stability | -0.1 unit on a scale | Standard Error 0.35 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upright Stability | -0.3 unit on a scale | Standard Error 0.48 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Bulbar | 0.15 unit on a scale | Standard Error 0.112 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Lower Limb Coordination | -0.52 unit on a scale | Standard Error 0.415 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Lower Limb Coordination | -0.63 unit on a scale | Standard Error 0.625 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Bulbar | -0.08 unit on a scale | Standard Error 0.102 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upper Limb Coordination | 0.02 unit on a scale | Standard Error 0.848 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upright Stability | -0.8 unit on a scale | Standard Error 0.38 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Bulbar | 0.06 unit on a scale | Standard Error 0.118 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Lower Limb Coordination | -0.88 unit on a scale | Standard Error 0.691 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upper Limb Coordination | 0.17 unit on a scale | Standard Error 0.741 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upper Limb Coordination | 0.44 unit on a scale | Standard Error 0.601 |
| TAK-831 75 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upright Stability | -0.3 unit on a scale | Standard Error 0.53 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upper Limb Coordination | -0.53 unit on a scale | Standard Error 0.419 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upper Limb Coordination | -0.72 unit on a scale | Standard Error 0.547 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Upright Stability | 0.5 unit on a scale | Standard Error 0.38 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upper Limb Coordination | -0.65 unit on a scale | Standard Error 0.602 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Lower Limb Coordination | -0.14 unit on a scale | Standard Error 0.289 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Lower Limb Coordination | -0.67 unit on a scale | Standard Error 0.516 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Upright Stability | 0.4 unit on a scale | Standard Error 0.28 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 2, Bulbar | 0.14 unit on a scale | Standard Error 0.082 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 7, Bulbar | 0.17 unit on a scale | Standard Error 0.079 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Lower Limb Coordination | -0.67 unit on a scale | Standard Error 0.445 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Bulbar | 0.21 unit on a scale | Standard Error 0.087 |
| TAK-831 300 mg | Change From Baseline in the mFARS-neuro Subscales Scores | Change at Week 12, Upright Stability | 0.4 unit on a scale | Standard Error 0.34 |
Comparison: Change at Week 2, Bulbar90% CI: [-0.15, 0.29]
Comparison: Change at Week 2, Bulbar90% CI: [-0.12, 0.25]
Comparison: Change at Week 7, Bulbar90% CI: [-0.3, 0.11]
Comparison: Change at Week 7, Bulbar90% CI: [-0.02, 0.33]
Comparison: Change at Week 12, Bulbar90% CI: [-0.19, 0.28]
Comparison: Change at Week 12, Bulbar90% CI: [0, 0.4]
Comparison: Change at Week 2, Upper Limb Coordination90% CI: [0.83, 3.14]
Comparison: Change at Week 2, Upper Limb Coordination90% CI: [0.06, 1.97]
Comparison: Change at Week 7, Upper Limb Coordination90% CI: [-0.4, 2.55]
Comparison: Change at Week 7, Upper Limb Coordination90% CI: [-1.06, 1.43]
Comparison: Change at Week 12, Upper Limb Coordination90% CI: [-0.48, 2.91]
Comparison: Change at Week 12, Upper Limb Coordination90% CI: [-0.87, 1.94]
Comparison: Change at Week 2, Lower Limb Coordination90% CI: [-0.41, 1.2]
Comparison: Change at Week 2, Lower Limb Coordination90% CI: [0.12, 1.45]
Comparison: Change at Week 7, Lower Limb Coordination90% CI: [-1.44, 1.36]
Comparison: Change at Week 7, Lower Limb Coordination90% CI: [-1.01, 1.36]
Comparison: Change at Week 12, Lower Limb Coordination90% CI: [-0.27, 2.25]
Comparison: Change at Week 12, Lower Limb Coordination90% CI: [-0.09, 2]
Comparison: Change at Week 2, Upright Stability90% CI: [-0.8, 1.3]
Comparison: Change at Week 2, Upright Stability90% CI: [0.1, 1.9]
Comparison: Change at Week 7, Upright Stability90% CI: [-1.3, 0.2]
Comparison: Change at Week 7, Upright Stability90% CI: [0, 1.2]
Comparison: Change at Week 12, Upright Stability90% CI: [-1.2, 0.7]
Comparison: Change at Week 12, Upright Stability90% CI: [-0.3, 1.3]
Secondary
Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score
The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36 for a total possible score of 0 to 99 with higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by-visit interactions.
Time frame: Baseline and Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 7 | -2.41 score on a scale | Standard Error 0.799 |
| Placebo | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 2 | -3.36 score on a scale | Standard Error 0.65 |
| Placebo | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 12 | -3.30 score on a scale | Standard Error 0.762 |
| TAK-831 75 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 7 | -2.01 score on a scale | Standard Error 1.114 |
| TAK-831 75 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 2 | -0.70 score on a scale | Standard Error 0.919 |
| TAK-831 75 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 12 | -1.28 score on a scale | Standard Error 1.057 |
| TAK-831 300 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 2 | -0.58 score on a scale | Standard Error 0.647 |
| TAK-831 300 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 12 | -1.19 score on a scale | Standard Error 0.752 |
| TAK-831 300 mg | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Change from Baseline at Week 7 | -1.35 score on a scale | Standard Error 0.828 |
Comparison: Change from Baseline at Week 2p-value: 0.99290% CI: [0.86, 4.47]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.99990% CI: [1.29, 4.28]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.61690% CI: [-1.84, 2.64]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.82390% CI: [-0.83, 2.95]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.94290% CI: [-0.1, 4.13]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.97590% CI: [0.35, 3.87]ANCOVA
Secondary
Change From Baseline in the Timed 25-Foot Walk (T25FW)
The participant was instructed to walk 25 feet as quickly as possible, but safely. The time was calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task was immediately administered again by having the participant walk back the same distance. The two trials were averaged. A negative change from Baseline indicates improvement. Change from Baseline in T25FW was analyzed using MMRM ANCOVA with Baseline T25FW as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline T25FW-by-visit interactions.
Time frame: Baseline and Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 7 | 1.67 seconds | Standard Error 0.948 |
| Placebo | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 2 | 0.61 seconds | Standard Error 0.901 |
| Placebo | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 12 | 0.52 seconds | Standard Error 0.903 |
| TAK-831 75 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 7 | 1.77 seconds | Standard Error 1.255 |
| TAK-831 75 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 2 | 0.84 seconds | Standard Error 1.124 |
| TAK-831 75 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 12 | 2.70 seconds | Standard Error 1.226 |
| TAK-831 300 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 2 | 1.95 seconds | Standard Error 0.99 |
| TAK-831 300 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 12 | 1.30 seconds | Standard Error 1.057 |
| TAK-831 300 mg | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Change from Baseline at Week 7 | 1.37 seconds | Standard Error 1.08 |
Comparison: Change from Baseline at Week 2p-value: 0.59990% CI: [-1.31, 1.76]ANCOVA
Comparison: Change from Baseline at Week 2p-value: 0.97890% CI: [0.26, 2.42]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.53390% CI: [-1.87, 2.06]ANCOVA
Comparison: Change from Baseline at Week 7p-value: 0.3790% CI: [-1.83, 1.23]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.97290% CI: [0.32, 4.04]ANCOVA
Comparison: Change from Baseline at Week 12p-value: 0.82590% CI: [-0.63, 2.19]ANCOVA
Secondary
Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories
The clinician used the CGI-I scale to assess the participant's improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 12 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 11 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 1 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 9 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 1 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 2 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 13 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 1 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 10 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 14 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 1 Participants |
| Placebo | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 1 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 11 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 6 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 1 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 7 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 5 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 2 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 7 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 16 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 11 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 7 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 3 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 9 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 15 Participants |
| TAK-831 300 mg | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 0 Participants |
Comparison: Week 2p-value: 0.987Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.771Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.526Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.665Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.576Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.865Cochran-Mantel-Haenszel
Secondary
Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline
The clinician used the CGI-S scale to assess the severity of the participant's upper extremity function on a 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Baseline and Week 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 7 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 10 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 4 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 9 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 4 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 13 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 11 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 10 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 3 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 5 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 4 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 3 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 5 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 3 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 5 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 11 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 9 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 8 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 8 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 3 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 8 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 9 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 4 Participants |
| TAK-831 300 mg | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 1 Participants |
Comparison: Week 2p-value: 0.406Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.235Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.225Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.434Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.249Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.38Cochran-Mantel-Haenszel
Secondary
Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories
The clinician used the CGI-I scale to assess the participant's improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 14 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, No Change | 11 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A little Worse | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 13 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, No Change | 11 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A little Worse | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 9 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, No Change | 12 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A little Worse | 2 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A little Worse | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, No Change | 8 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 3 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 4 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, No Change | 7 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, No Change | 10 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A little Worse | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 3 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 7 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 8 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, No Change | 11 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 7, A little Worse | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, No Change | 16 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 2 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 6 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 2, No Change | 17 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Week 12, A little Worse | 1 Participants |
Comparison: Week 2p-value: 0.974Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.893Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.954Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.793Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.845Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.816Cochran-Mantel-Haenszel
Secondary
Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline
The clinician used the CGI-S scale to assess the severity of the participant's disease overall on a 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 14 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 4 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 3 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 13 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 4 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 14 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=2 (Moderate) | 3 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 6 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 8 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 8 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=4 (Very Severe) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 9 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 8 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 11 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 7 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 11 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 10 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 3 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
Comparison: Week 2p-value: 0.666Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.812Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.834Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.841Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.893Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.907Cochran-Mantel-Haenszel
Secondary
Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories
The participant used the PGI-I scale to assess their improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Weeks 2, 7 and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 8 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 10 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, No Change | 19 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 5 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, No Change | 11 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 6 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Much Improved | 1 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A little Worse | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, No Change | 7 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A little Worse | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Worse | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 3 Participants |
| Placebo | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A little Worse | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 4 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, No Change | 10 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 4 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, No Change | 8 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A little Worse | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Much Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, No Change | 7 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A little Worse | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A little Worse | 4 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Improved | 1 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, Moderately Improved | 3 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A little Worse | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, A Little Improved | 3 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, No Change | 16 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, No Change | 15 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 2, A Little Improved | 8 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A little Worse | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, No Change | 14 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Moderately Worse | 1 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 12, Much Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Week 7, A Little Improved | 5 Participants |
Comparison: Week 2p-value: 0.84Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.854Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.922Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.794Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.83Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.998Cochran-Mantel-Haenszel
Secondary
Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline
The participant assessed the severity of their disease overall using the PGI-S 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=1 (Mild) | 4 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=2 (Moderate) | 1 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 3 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 5 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 4 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 11 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 12 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 10 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 4 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 3 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 4 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| Placebo | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=4 (Very Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 5 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 4 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 4 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 75 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=3 (Severe) | 4 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=3 (Severe) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=3 (Severe) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=2 (Moderate) | 3 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=2 (Moderate) | 16 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=2 (Moderate) | 15 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=2 (Moderate) | 14 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=3 (Severe) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=3 (Severe) | Score at Baseline=2 (Moderate) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=3 (Severe) | 3 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=2 (Moderate) | Score at Baseline=0 (No Symptoms) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=1 (Mild) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=3 (Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=2 (Moderate) | 1 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=2 (Moderate) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 12=2 (Moderate) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=3 (Severe) | 3 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=1 (Mild) | Score at Baseline=1 (Mild) | 2 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 2=1 (Mild) | Score at Baseline=4 (Very Severe) | 0 Participants |
| TAK-831 300 mg | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Score at Week 7=3 (Severe) | Score at Baseline=4 (Very Severe) | 0 Participants |
Comparison: Week 2p-value: 0.032Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.216Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.215Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.411Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.194Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.408Cochran-Mantel-Haenszel
Secondary
Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories
The participant used the PGI-I scale to assess their improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 6 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 3 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 16 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Much Improved | 2 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 10 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 6 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 2 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 11 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 6 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 0 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 1 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 5 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Much Improved | 0 Participants |
| Placebo | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 9 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 3 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 10 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Much Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 4 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 7 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 2 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Much Improved | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 4 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 7 Participants |
| TAK-831 75 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, No Change | 15 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Much Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Much Improved | 1 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A little Worse | 1 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, Moderately Improved | 1 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, No Change | 18 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, Moderately Improved | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A Little Improved | 6 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 2, A Little Improved | 7 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, No Change | 15 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A Little Improved | 4 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 12, A little Worse | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, A little Worse | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Week 7, Moderately Improved | 2 Participants |
Comparison: Week 2p-value: 0.966Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.983Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.953Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.781Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.948Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.998Cochran-Mantel-Haenszel
Secondary
Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories
The participant assessed the severity of their upper extremity function using the PGI-S 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.
Time frame: Baseline and Weeks 2, 7, and 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 8 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 8 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 11 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 3 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 11 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 3 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 9 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 11 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 1 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| Placebo | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 5 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 3 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 3 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 4 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 7 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 1 Participants |
| TAK-831 75 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 9 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 11 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 6 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 3 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 3 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 5 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 4 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 3 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=3 (Severely Impaired) | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=2 (Moderately Impaired) | 5 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=2 (Moderately Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=1 (Mildly Impaired) | 9 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=1 (Mildly Impaired) | 2 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=1 (Mildly Impaired) | Score at Baseline=0 (Not Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=1 (Mildly Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=4 (Very Severely Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 2=0 (Not Impaired) | Score at Baseline=1 (Mildly Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=2 (Moderately Impaired) | 0 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=0 (Not Impaired) | Score at Baseline=3 (Severely Impaired) | 1 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 12=2 (Moderately Impaired) | Score at Baseline=2 (Moderately Impaired) | 6 Participants |
| TAK-831 300 mg | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Score at Week 7=3 (Severely Impaired) | Score at Baseline=3 (Severely Impaired) | 0 Participants |
Comparison: Week 2p-value: 0.422Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.226Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.639Cochran-Mantel-Haenszel
Comparison: Week 7p-value: 0.094Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.516Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.266Cochran-Mantel-Haenszel
Secondary
Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline
The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time.
Time frame: Baseline up to Week 12
Population: FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 15% Reduction from Baseline | 3 Participants |
| Placebo | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 20% Reduction from Baseline | 2 Participants |
| TAK-831 75 mg | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 15% Reduction from Baseline | 0 Participants |
| TAK-831 75 mg | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 20% Reduction from Baseline | 0 Participants |
| TAK-831 300 mg | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 15% Reduction from Baseline | 0 Participants |
| TAK-831 300 mg | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | At Least 20% Reduction from Baseline | 0 Participants |
Comparison: At Least 15% Reduction from Baselinep-value: >0.999Fisher Exact
Comparison: At Least 15% Reduction from Baselinep-value: >0.999Fisher Exact
Comparison: At Least 20% Reduction from Baselinep-value: >0.999Fisher Exact
Comparison: At Least 20% Reduction from Baselinep-value: >0.999Fisher Exact