Huntington Disease
Conditions
Keywords
Huntington Disease
Brief summary
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
Detailed description
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD.
Interventions
DRUGPridopidine
Pridopidine hard gelatin capsule
DRUGPlacebo
Pridopidine-matching placebo hard gelatin capsule
Sponsors
Prilenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
MAIN STUDY 1. Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene 2. Diagnostic confidence level (DCL) of 4 3. Adult-onset HD with onset of signs and symptoms ≥18 years of age 4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening
Exclusion criteria
1. Use of pridopidine within 12 months before the baseline visit. 2. Gene therapy at any time 3. Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias 4. History of epilepsy or seizures within the last 5 years 5. Pregnant or breastfeeding, or intention to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT) | From baseline to Week 65 | The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity. |
| Change From Baseline to Week 65 in the UHDRS TFC Score (ITT) | From baseline to Week 65. | The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT) | From baseline to Week 65 | The composite Unified Huntington Disease Rating Scale (cUHDRS) uses 4 components: Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0. Total integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 52, Week 65, and Week 78. | Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assess the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is IOI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78 | Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78 | The composite Unified Huntington Disease Rating Scale (cUHDRS) assesses 4 components (see secondary outcome for details): Total Motor Score (TMS) for motor features. Higher score = worse outcome. Worst = 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Higher score = better outcome. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Higher score = better outcome. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. The higher, the better. Total cUHDRS scale range: -7.6 to 24.8 (assuming 150 as the max score of SWR). The higher, the better. This sensitivity analysis was performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78. | Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to write match numbers with symbols. Scoring sums correct substitutions in 90 second interval (max = 110). Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78. | Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Each rated 0 (normal) - 4 (abnormal). Higher score = worse outcome. Worst = 124. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78 | Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 52, Week 65, and Week 78. | Quantitative (Q)-motor is a clinical assessment of fine motor skills. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. The index finger is positioned above a force transducer and is to tap as fast as possible. The start was defined as a rise of the force by 0.05 Newton above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. The IOI refers to the time between the onset of consecutive taps (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
| Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Time course from baseline to Week 26, Week 52, Week 65, and Week 78. | Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assesses the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is ITI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study. |
Countries
Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pridopidine 45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule | 250 |
| Placebo Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule | 249 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 7 |
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Not further specified | 2 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 14 | 12 |
Baseline characteristics
| Characteristic | Total | Pridopidine | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 79 Participants | 43 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 420 Participants | 207 Participants | 213 Participants |
| Age, Continuous | 52.5 years STANDARD_DEVIATION 11.66 | 52.2 years STANDARD_DEVIATION 11.93 | 52.7 years STANDARD_DEVIATION 11.39 |
| HD stage at randomization HD1 | 205 Participants | 102 Participants | 103 Participants |
| HD stage at randomization HD2 | 294 Participants | 148 Participants | 146 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 477 Participants | 242 Participants | 235 Participants |
| Region of Enrollment Austria | 11 participants | 5 participants | 6 participants |
| Region of Enrollment Canada | 26 participants | 9 participants | 17 participants |
| Region of Enrollment Czechia | 14 participants | 6 participants | 8 participants |
| Region of Enrollment France | 11 participants | 4 participants | 7 participants |
| Region of Enrollment Germany | 78 participants | 37 participants | 41 participants |
| Region of Enrollment Italy | 58 participants | 28 participants | 30 participants |
| Region of Enrollment Netherlands | 22 participants | 14 participants | 8 participants |
| Region of Enrollment Poland | 31 participants | 16 participants | 15 participants |
| Region of Enrollment Spain | 29 participants | 18 participants | 11 participants |
| Region of Enrollment United Kingdom | 18 participants | 5 participants | 13 participants |
| Region of Enrollment United States | 201 participants | 108 participants | 93 participants |
| Sex: Female, Male Female | 259 Participants | 132 Participants | 127 Participants |
| Sex: Female, Male Male | 240 Participants | 118 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 250 | 1 / 249 |
| other Total, other adverse events | 204 / 250 | 212 / 249 |
| serious Total, serious adverse events | 34 / 250 | 21 / 249 |
Outcome results
Primary
Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
Time frame: From baseline to Week 65
Population: The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized.~The mITT population was the main analysis population for the primary endpoint in non-EMA regions. Note that the analysis was based on observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pridopidine | Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT) | -1.18 score on a scale | Standard Error 0.119 |
| Placebo | Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT) | -0.95 score on a scale | Standard Error 0.119 |
Comparison: In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.p-value: 0.16795% CI: [-0.54, 0.09]Mixed Models Analysis
Primary
Change From Baseline to Week 65 in the UHDRS TFC Score (ITT)
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
Time frame: From baseline to Week 65.
Population: The intent to treat (ITT) population included all randomized participants. The ITT population was analyzed according to the treatment to which the participant was randomized.~The ITT population was the main analysis population for the primary endpoint in the EMA region.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pridopidine | Change From Baseline to Week 65 in the UHDRS TFC Score (ITT) | -1.17 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline to Week 65 in the UHDRS TFC Score (ITT) | -0.94 score on a scale | Standard Error 0.12 |
Comparison: In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.p-value: 0.159895% CI: [-0.55, 0.09]Mixed Models Analysis
Secondary
Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT)
The composite Unified Huntington Disease Rating Scale (cUHDRS) uses 4 components: Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0. Total integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.
Time frame: From baseline to Week 65
Population: The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in-clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized. Note that the analysis was based on as observed data only, patient numbers are therefore lower.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pridopidine | Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT) | -0.99 score on a scale | Standard Error 0.109 |
| Placebo | Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT) | -0.88 score on a scale | Standard Error 0.108 |
Comparison: In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.p-value: 0.454495% CI: [-0.4, 0.18]Mixed Models Analysis
Other Pre-specified
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
The composite Unified Huntington Disease Rating Scale (cUHDRS) assesses 4 components (see secondary outcome for details): Total Motor Score (TMS) for motor features. Higher score = worse outcome. Worst = 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Higher score = better outcome. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Higher score = better outcome. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. The higher, the better. Total cUHDRS scale range: -7.6 to 24.8 (assuming 150 as the max score of SWR). The higher, the better. This sensitivity analysis was performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 39 | 0.10 score on a scale | Standard Error 0.13 |
| Pridopidine | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 65 | -0.26 score on a scale | Standard Error 0.143 |
| Pridopidine | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 52 | -0.07 score on a scale | Standard Error 0.14 |
| Pridopidine | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 78 | -0.40 score on a scale | Standard Error 0.159 |
| Pridopidine | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 26 | 0.15 score on a scale | Standard Error 0.114 |
| Placebo | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 78 | -0.54 score on a scale | Standard Error 0.158 |
| Placebo | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 26 | -0.31 score on a scale | Standard Error 0.108 |
| Placebo | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 39 | -0.34 score on a scale | Standard Error 0.125 |
| Placebo | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 52 | -0.48 score on a scale | Standard Error 0.135 |
| Placebo | Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT) | Week 65 | -0.53 score on a scale | Standard Error 0.137 |
Comparison: From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.003895% CI: [0.15, 0.76]Mixed Models Analysis
Comparison: From baseline to Week 39p-value: 0.013595% CI: [0.09, 0.8]Mixed Models Analysis
Comparison: From baseline to Week 52p-value: 0.035195% CI: [0.03, 0.79]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.168395% CI: [-0.12, 0.66]Mixed Models Analysis
Comparison: From baseline to Week 78p-value: 0.531595% CI: [-0.3, 0.58]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)
Quantitative (Q)-motor is a clinical assessment of fine motor skills. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. The index finger is positioned above a force transducer and is to tap as fast as possible. The start was defined as a rise of the force by 0.05 Newton above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. The IOI refers to the time between the onset of consecutive taps (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 26 | -14.85 milliseconds (decrease = improvement) | Standard Error 6.846 |
| Pridopidine | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 52 | -2.37 milliseconds (decrease = improvement) | Standard Error 7.135 |
| Pridopidine | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 65 | -0.79 milliseconds (decrease = improvement) | Standard Error 7.365 |
| Pridopidine | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 78 | 1.46 milliseconds (decrease = improvement) | Standard Error 7.444 |
| Placebo | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 78 | 24.36 milliseconds (decrease = improvement) | Standard Error 7.23 |
| Placebo | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 26 | 6.30 milliseconds (decrease = improvement) | Standard Error 6.449 |
| Placebo | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 65 | 23.93 milliseconds (decrease = improvement) | Standard Error 7.028 |
| Placebo | Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 52 | 11.95 milliseconds (decrease = improvement) | Standard Error 6.792 |
Comparison: From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.p-value: 0.025395% CI: [-39.66, -2.64]Mixed Models Analysis
Comparison: From baseline to Week 52.p-value: 0.147495% CI: [-33.71, 5.08]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.015995% CI: [-44.76, -4.67]Mixed Models Analysis
Comparison: From baseline to Week 78.p-value: 0.028395% CI: [-43.34, -2.45]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assesses the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is ITI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 26 | -17.63 milliseconds | Standard Error 8.029 |
| Pridopidine | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 52 | -0.15 milliseconds | Standard Error 9.124 |
| Pridopidine | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 65 | 4.64 milliseconds | Standard Error 8.38 |
| Pridopidine | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 78 | 12.73 milliseconds | Standard Error 9.74 |
| Placebo | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 78 | 34.97 milliseconds | Standard Error 9.412 |
| Placebo | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 26 | 20.43 milliseconds | Standard Error 7.448 |
| Placebo | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 65 | 28.55 milliseconds | Standard Error 7.867 |
| Placebo | Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT) | Week 52 | 20.07 milliseconds | Standard Error 8.555 |
Comparison: From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.000795% CI: [-59.74, -16.37]Mixed Models Analysis
Comparison: From baseline to Week 52.p-value: 0.108795% CI: [-44.95, 4.53]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.039595% CI: [-46.68, -1.16]Mixed Models Analysis
Comparison: From baseline to Week 78.p-value: 0.103895% CI: [-49.08, 4.61]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 39 | 2.85 score on a scale | Standard Error 1.1 |
| Pridopidine | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 65 | 1.39 score on a scale | Standard Error 1.243 |
| Pridopidine | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 52 | 2.73 score on a scale | Standard Error 1.078 |
| Pridopidine | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 78 | 0.91 score on a scale | Standard Error 1.261 |
| Pridopidine | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 26 | 2.34 score on a scale | Standard Error 0.964 |
| Placebo | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 78 | -1.08 score on a scale | Standard Error 1.249 |
| Placebo | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 26 | -0.82 score on a scale | Standard Error 0.916 |
| Placebo | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 39 | -0.04 score on a scale | Standard Error 1.051 |
| Placebo | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 52 | -0.32 score on a scale | Standard Error 1.039 |
| Placebo | Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT) | Week 65 | -0.94 score on a scale | Standard Error 1.193 |
Comparison: From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.017895% CI: [0.55, 5.77]Mixed Models Analysis
Comparison: From baseline to Week 39.p-value: 0.057695% CI: [-0.09, 5.88]Mixed Models Analysis
Comparison: From baseline to Week 52.p-value: 0.041895% CI: [0.11, 5.99]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.177595% CI: [-1.06, 5.71]Mixed Models Analysis
Comparison: From baseline to Week 78.p-value: 0.262795% CI: [-1.5, 5.48]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to write match numbers with symbols. Scoring sums correct substitutions in 90 second interval (max = 110). Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.
Population: Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 39 | 0.82 score on a scale | Standard Error 0.512 |
| Pridopidine | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 65 | 0.35 score on a scale | Standard Error 0.616 |
| Pridopidine | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 52 | -0.42 score on a scale | Standard Error 0.578 |
| Pridopidine | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 78 | 0.07 score on a scale | Standard Error 0.617 |
| Pridopidine | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 26 | 0.54 score on a scale | Standard Error 0.521 |
| Placebo | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 78 | -0.36 score on a scale | Standard Error 0.598 |
| Placebo | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 26 | -0.47 score on a scale | Standard Error 0.484 |
| Placebo | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 39 | -0.06 score on a scale | Standard Error 0.478 |
| Placebo | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 52 | -0.33 score on a scale | Standard Error 0.543 |
| Placebo | Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT) | Week 65 | 0.07 score on a scale | Standard Error 0.576 |
Comparison: From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.158695% CI: [-0.4, 2.41]Mixed Models Analysis
Comparison: From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.214495% CI: [-0.51, 2.25]Mixed Models Analysis
Comparison: From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.911995% CI: [-1.65, 1.48]Mixed Models Analysis
Comparison: From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.733995% CI: [-1.38, 1.95]Mixed Models Analysis
Comparison: From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.621395% CI: [-1.27, 2.12]Mixed Models Analysis
Other Pre-specified
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 39 | -0.11 score on a scale | Standard Error 0.137 |
| Pridopidine | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 65 | -0.49 score on a scale | Standard Error 0.156 |
| Pridopidine | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 52 | -0.19 score on a scale | Standard Error 0.149 |
| Pridopidine | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 78 | -0.42 score on a scale | Standard Error 0.166 |
| Pridopidine | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 26 | -0.01 score on a scale | Standard Error 0.131 |
| Placebo | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 78 | -0.54 score on a scale | Standard Error 0.163 |
| Placebo | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 26 | -0.23 score on a scale | Standard Error 0.124 |
| Placebo | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 39 | -0.31 score on a scale | Standard Error 0.131 |
| Placebo | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 52 | -0.45 score on a scale | Standard Error 0.143 |
| Placebo | Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT) | Week 65 | -0.54 score on a scale | Standard Error 0.15 |
Comparison: From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.208895% CI: [-0.13, 0.58]Mixed Models Analysis
Comparison: From baseline to Week 39.p-value: 0.299195% CI: [-0.17, 0.57]Mixed Models Analysis
Comparison: From baseline to Week 52.p-value: 0.211695% CI: [-0.15, 0.66]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.824295% CI: [-0.38, 0.47]Mixed Models Analysis
Comparison: From baseline to Week 78.p-value: 0.591895% CI: [-0.33, 0.58]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Each rated 0 (normal) - 4 (abnormal). Higher score = worse outcome. Worst = 124. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.
Population: Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 39 | 0.06 score on a scale | Standard Error 0.78 |
| Pridopidine | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 65 | 0.92 score on a scale | Standard Error 0.847 |
| Pridopidine | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 52 | 0.47 score on a scale | Standard Error 0.766 |
| Pridopidine | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 78 | 2.19 score on a scale | Standard Error 0.954 |
| Pridopidine | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 26 | -0.21 score on a scale | Standard Error 0.568 |
| Placebo | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 78 | 1.63 score on a scale | Standard Error 0.916 |
| Placebo | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 26 | -0.03 score on a scale | Standard Error 0.53 |
| Placebo | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 39 | 0.96 score on a scale | Standard Error 0.729 |
| Placebo | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 52 | 0.80 score on a scale | Standard Error 0.72 |
| Placebo | Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT) | Week 65 | 1.28 score on a scale | Standard Error 0.79 |
Comparison: From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.669495% CI: [-2.05, 3.18]Mixed Models Analysis
Comparison: From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.820595% CI: [-1.71, 1.36]Mixed Models Analysis
Comparison: From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.402895% CI: [-3, 1.21]Mixed Models Analysis
Comparison: From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.757795% CI: [-2.4, 1.75]Mixed Models Analysis
Comparison: From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.760595% CI: [-2.64, 1.93]Mixed Models Analysis
Other Pre-specified
Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assess the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is IOI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Time frame: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.
Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pridopidine | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 26 | -16.70 milliseconds | Standard Error 9.399 |
| Pridopidine | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 52 | 7.40 milliseconds | Standard Error 10.978 |
| Pridopidine | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 65 | 7.34 milliseconds | Standard Error 10.73 |
| Pridopidine | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 78 | 19.21 milliseconds | Standard Error 12.702 |
| Placebo | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 78 | 41.93 milliseconds | Standard Error 12.435 |
| Placebo | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 26 | 13.68 milliseconds | Standard Error 8.829 |
| Placebo | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 65 | 30.13 milliseconds | Standard Error 10.232 |
| Placebo | Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT) | Week 52 | 24.23 milliseconds | Standard Error 10.467 |
Comparison: From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.p-value: 0.019395% CI: [-55.78, -4.98]Mixed Models Analysis
Comparison: From baseline to Week 52.p-value: 0.26895% CI: [-46.69, 13.02]Mixed Models Analysis
Comparison: From baseline to Week 65.p-value: 0.125595% CI: [-51.97, 6.4]Mixed Models Analysis
Comparison: From baseline to Week 78.p-value: 0.202495% CI: [-57.72, 12.28]Mixed Models Analysis