Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease (PD)
Conditions
Keywords
Levodopa Induced Dyskinesia, LID, Parkinsonism, Parkinson's Disease
Brief summary
This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).
Detailed description
Participation in this study was offered to subjects who were described by one of the following 3 groups: * Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chose to immediately transition into the current study without a time gap; this group was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the previous Adamas efficacy study, and Group 1P, consisting of subjects who received placebo in the previous Adamas efficacy study * Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap * Group 3: Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing. Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.
Interventions
DRUGADS-5102
Sponsors
Adamas Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed a current IRB/REB/IEC-approved informed consent form * Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation. * Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria * On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily. * History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator
Exclusion criteria
* Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102 * History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation * History of seizures since completion of participation in previous Adamas studies or within 2 years * History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years * History of cancer since completion of participation in previous Adamas studies or within 2 years, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer * Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening * If female is pregnant or lactating * If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment. * Treatment with an investigational drug (other than ADS-5102) or device within 30 days prior to screening * Treatment with an investigational biologic within 6 months prior to screening * Current or planned participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Up to 101 weeks | The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). | To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III. Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4). Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Parts I, II, and III are summed to make the total score. |
| Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). | This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24 |
Countries
Austria, Canada, France, Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1a Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study. | 60 |
| Group 1P Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study | 78 |
| Group 2 Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap. | 24 |
| Group 3 Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation) | 61 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 19 | 5 | 9 |
| Overall Study | DBS surgery | 3 | 0 | 0 | 0 |
| Overall Study | Death | 3 | 2 | 1 | 1 |
| Overall Study | Dyskinesia upon taper | 1 | 0 | 0 | 0 |
| Overall Study | eGFR<50mL/min/m2 | 2 | 2 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Needed to take excluded medication | 0 | 2 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Site closure | 3 | 0 | 0 | 1 |
| Overall Study | Sponsor's decision | 2 | 0 | 0 | 0 |
| Overall Study | Subject consent withdrawn | 0 | 3 | 1 | 2 |
| Overall Study | Subject moved away | 0 | 1 | 0 | 0 |
| Overall Study | Subject unwilling to proceed | 1 | 5 | 3 | 5 |
| Overall Study | Unable to complete visits per protocol | 1 | 0 | 0 | 0 |
| Overall Study | Worsening Dyskinesia | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 48 Participants | 12 Participants | 22 Participants | 114 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 30 Participants | 12 Participants | 39 Participants | 109 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 9.81 | 65.9 years STANDARD_DEVIATION 8.8 | 64.4 years STANDARD_DEVIATION 7.81 | 60.2 years STANDARD_DEVIATION 9.2 | 63.7 years STANDARD_DEVIATION 9.32 |
| Body Mass Index | 25.86 kg/m^2 STANDARD_DEVIATION 25.42 | 25.72 kg/m^2 STANDARD_DEVIATION 24.63 | 25.26 kg/m^2 STANDARD_DEVIATION 23.24 | 27.29 kg/m^2 STANDARD_DEVIATION 4.891 | 26.14 kg/m^2 STANDARD_DEVIATION 5.22 |
| eGFR | 88.7 mL/min/1.73 m^2 STANDARD_DEVIATION 24.31 | 92.2 mL/min/1.73 m^2 STANDARD_DEVIATION 19.64 | 96.3 mL/min/1.73 m^2 STANDARD_DEVIATION 20.54 | 92.1 mL/min/1.73 m^2 STANDARD_DEVIATION 19.95 | 91.6 mL/min/1.73 m^2 STANDARD_DEVIATION 21.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 57 Participants | 74 Participants | 23 Participants | 54 Participants | 208 Participants |
| Sex: Female, Male Female | 26 Participants | 33 Participants | 13 Participants | 20 Participants | 92 Participants |
| Sex: Female, Male Male | 34 Participants | 45 Participants | 11 Participants | 41 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 60 | 2 / 78 | 2 / 24 | 1 / 61 |
| other Total, other adverse events | 47 / 60 | 61 / 78 | 21 / 24 | 45 / 61 |
| serious Total, serious adverse events | 16 / 60 | 21 / 78 | 6 / 24 | 17 / 61 |
Outcome results
Primary
Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations
The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
Time frame: Up to 101 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | AE | 57 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Study drug-related AE | 31 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | SAEs | 16 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to AE | 12 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate drug-related AE | 12 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to drug-related AE | 4 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild AEs | 12 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate AEs | 25 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild drug-related AE | 16 Participants |
| Group 1a | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Severe drug-related AE | 3 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate drug-related AE | 23 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | SAEs | 21 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate AEs | 36 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Severe drug-related AE | 7 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Study drug-related AE | 45 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to AE | 21 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild drug-related AE | 15 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild AEs | 13 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | AE | 70 Participants |
| Group 1P | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to drug-related AE | 15 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | SAEs | 6 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate AEs | 13 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild AEs | 3 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild drug-related AE | 3 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate drug-related AE | 12 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Severe drug-related AE | 1 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to AE | 6 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | AE | 23 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to drug-related AE | 4 Participants |
| Group 2 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Study drug-related AE | 16 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate AEs | 26 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild drug-related AE | 5 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Study drug-related AE | 32 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | AE | 55 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to drug-related AE | 8 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Mild AEs | 11 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Severe drug-related AE | 5 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | SAEs | 17 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Permanent discontinuation due to AE | 10 Participants |
| Group 3 | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Moderate drug-related AE | 22 Participants |
Secondary
Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)
This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24
Time frame: 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 64 | 0.4 units on a scale | Standard Deviation 3.82 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 28 | -0.3 units on a scale | Standard Deviation 3.61 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 88 | 0.4 units on a scale | Standard Deviation 3.77 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 16 | -0.8 units on a scale | Standard Deviation 3.61 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Baseline | 6.5 units on a scale | Standard Deviation 3.38 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 52 | 0.2 units on a scale | Standard Deviation 3.64 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 8 | -0.2 units on a scale | Standard Deviation 3.21 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 100 | 0.4 units on a scale | Standard Deviation 3.28 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 76 | 0.9 units on a scale | Standard Deviation 4.2 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 40 | 0.0 units on a scale | Standard Deviation 3.95 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 8 | -3.4 units on a scale | Standard Deviation 3.27 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 64 | -3.3 units on a scale | Standard Deviation 3.42 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 52 | -2.9 units on a scale | Standard Deviation 3.56 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Baseline | 9.6 units on a scale | Standard Deviation 3.07 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 100 | -2.4 units on a scale | Standard Deviation 4.19 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 88 | -2.8 units on a scale | Standard Deviation 3.6 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 40 | -2.8 units on a scale | Standard Deviation 3.39 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 16 | -3.2 units on a scale | Standard Deviation 3.61 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 76 | -2.9 units on a scale | Standard Deviation 3.67 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 28 | -3.3 units on a scale | Standard Deviation 3.12 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 16 | -1.1 units on a scale | Standard Deviation 5.03 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 76 | -2.7 units on a scale | Standard Deviation 3.9 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Baseline | 9.8 units on a scale | Standard Deviation 3.92 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 8 | -3.6 units on a scale | Standard Deviation 4.16 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 28 | -1.4 units on a scale | Standard Deviation 3.84 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 40 | -2.9 units on a scale | Standard Deviation 4.81 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 52 | -2.5 units on a scale | Standard Deviation 4.4 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 64 | -1.9 units on a scale | Standard Deviation 4.32 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 88 | -3.7 units on a scale | Standard Deviation 4.69 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 100 | -3.6 units on a scale | Standard Deviation 3.66 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 28 | -4.4 units on a scale | Standard Deviation 3.79 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 16 | -3.9 units on a scale | Standard Deviation 3.68 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change in Baseline from Week 8 | -4.0 units on a scale | Standard Deviation 4.2 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Baseline | 10.4 units on a scale | Standard Deviation 2.77 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 100 | -3.6 units on a scale | Standard Deviation 3.94 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 88 | -4.3 units on a scale | Standard Deviation 3.55 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 76 | -3.7 units on a scale | Standard Deviation 3.68 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 40 | -4.7 units on a scale | Standard Deviation 4.06 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 52 | -3.6 units on a scale | Standard Deviation 3.62 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | Change from Baseline at Week 64 | -2.5 units on a scale | Standard Deviation 4.22 |
Secondary
Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)
To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III. Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4). Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Parts I, II, and III are summed to make the total score.
Time frame: Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 88 | 11.3 units on a scale | Standard Deviation 16.65 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 16 | 1.6 units on a scale | Standard Deviation 13.41 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 100 | 11.4 units on a scale | Standard Deviation 15.66 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Baseline | 41.8 units on a scale | Standard Deviation 18.43 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 28 | 4.8 units on a scale | Standard Deviation 10.04 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 8 | 1.2 units on a scale | Standard Deviation 10.03 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 40 | 7.5 units on a scale | Standard Deviation 15.43 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 52 | 13.2 units on a scale | Standard Deviation 16.78 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 64 | 8.8 units on a scale | Standard Deviation 14.83 |
| Group 1a | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 76 | 11.7 units on a scale | Standard Deviation 19.58 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 8 | -2.8 units on a scale | Standard Deviation 14.11 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 88 | 3.7 units on a scale | Standard Deviation 13.8 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 76 | 7.3 units on a scale | Standard Deviation 19.18 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 64 | 2.6 units on a scale | Standard Deviation 14.57 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 100 | 3.7 units on a scale | Standard Deviation 15.29 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 40 | -0.4 units on a scale | Standard Deviation 15.2 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 16 | -1.4 units on a scale | Standard Deviation 16.22 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 52 | 2.6 units on a scale | Standard Deviation 14.57 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 28 | 1.5 units on a scale | Standard Deviation 12.49 |
| Group 1P | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Baseline | 45.6 units on a scale | Standard Deviation 19.24 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 64 | 6.1 units on a scale | Standard Deviation 18.34 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 8 | 0.8 units on a scale | Standard Deviation 12 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 28 | 6.5 units on a scale | Standard Deviation 14.18 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 76 | 9.4 units on a scale | Standard Deviation 19.1 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 52 | 6.1 units on a scale | Standard Deviation 18.34 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 88 | 6.4 units on a scale | Standard Deviation 22.65 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Baseline | 52.8 units on a scale | Standard Deviation 23.06 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 40 | 1.6 units on a scale | Standard Deviation 18.29 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 100 | 6.5 units on a scale | Standard Deviation 16.46 |
| Group 2 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 16 | 5.7 units on a scale | Standard Deviation 15.53 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 100 | 4.1 units on a scale | Standard Deviation 17.48 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Baseline | 52.4 units on a scale | Standard Deviation 16.55 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 8 | -5.3 units on a scale | Standard Deviation 10.74 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 16 | -5.2 units on a scale | Standard Deviation 11.33 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 28 | -5.3 units on a scale | Standard Deviation 12.99 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 52 | -4.6 units on a scale | Standard Deviation 15.6 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 64 | -4.6 units on a scale | Standard Deviation 15.6 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 76 | -4.9 units on a scale | Standard Deviation 13.83 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 88 | 0.9 units on a scale | Standard Deviation 16.18 |
| Group 3 | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | Change from Baseline at Week 40 | -4.8 units on a scale | Standard Deviation 12.49 |