Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease
Conditions
Keywords
Levodopa-induced dyskinesia, Parkinsonism
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
Interventions
DRUGADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Sponsors
Adamas Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed a current IRB/IEC-approved informed consent form * Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria * On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation * Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia) * Able to understand and complete a standardized PD home diary, following training
Exclusion criteria
* History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation) * History of seizures or stroke/TIA within 2 years of screening * History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer * Estimated GFR \< 50 mL/min/1.73m2 * 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, or has a positive pregnancy test result pre-dose * 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 or device within 30 days prior to screening * Treatment with an investigational biologic within 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity. |
| Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | Baseline (Day 1) and Week 8 | UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia. |
| Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | Baseline (Day 1) and Week 8 | A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit. |
| Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4. |
| Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). |
Countries
United States
Participant flow
Recruitment details
Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were enrolled at 31 study sites in the United States. The first subject was randomized on 03 August 2011 and the last subject completed on 15 April 2013.
Pre-assignment details
All randomized subjects (83) were treated and analyzed for safety; 80 were analyzed for efficacy and included in the Modified Intent to Treat (MITT) population. Subjects in the MITT had mild to severe dyskinesia, had periods of troublesome dyskinesia during the day, received ≥ 1 dose of study drug, and provided ≥ 1 postbaseline efficacy assessment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks | 22 |
| ADS-5102 (260 mg) 260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks | 20 |
| ADS-5102 (340 mg) 340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8) | 21 |
| ADS-5102 (420 mg) 420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8) | 20 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 3 | 8 |
| Overall Study | Increased bradykinesia related to PD | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | ADS-5102 (260 mg) | ADS-5102 (340 mg) | Placebo | ADS-5102 (420 mg) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 8.59 | 64.7 years STANDARD_DEVIATION 10.03 | 65.5 years STANDARD_DEVIATION 10.17 | 66.4 years STANDARD_DEVIATION 9.38 | 66.0 years STANDARD_DEVIATION 9.47 |
| Duration of LID | 3.35 years STANDARD_DEVIATION 2.585 | 4.37 years STANDARD_DEVIATION 3.364 | 4.08 years STANDARD_DEVIATION 4.051 | 3.57 years STANDARD_DEVIATION 2.049 | 3.85 years STANDARD_DEVIATION 3.106 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 21 Participants | 21 Participants | 18 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fatigue Severity Score (FSS) | 4.40 units on a scale STANDARD_DEVIATION 1.488 | 4.80 units on a scale STANDARD_DEVIATION 1.425 | 4.86 units on a scale STANDARD_DEVIATION 1.211 | 4.78 units on a scale STANDARD_DEVIATION 1.12 | 4.71 units on a scale STANDARD_DEVIATION 1.307 |
| Hoehn and Yahr Score | 2.5 units on a scale STANDARD_DEVIATION 0.9 | 2.5 units on a scale STANDARD_DEVIATION 0.6 | 2.5 units on a scale STANDARD_DEVIATION 0.7 | 2.4 units on a scale STANDARD_DEVIATION 0.8 | 2.5 units on a scale STANDARD_DEVIATION 0.7 |
| Levodopa daily dose | 714.5 mg STANDARD_DEVIATION 449.33 | 694.0 mg STANDARD_DEVIATION 278.33 | 801.1 mg STANDARD_DEVIATION 431.94 | 862.5 mg STANDARD_DEVIATION 585.94 | 768.6 mg STANDARD_DEVIATION 444.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 20 Participants | 20 Participants | 17 Participants | 75 Participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 8 Participants | 10 Participants | 38 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 14 Participants | 10 Participants | 45 Participants |
| Subjects taking Antiparkinson Medication Anticholinergic | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Subjects taking Antiparkinson Medication COMT Inhibitor | 1 Participants | 6 Participants | 3 Participants | 4 Participants | 14 Participants |
| Subjects taking Antiparkinson Medication Dopamine Agonist | 14 Participants | 10 Participants | 14 Participants | 16 Participants | 54 Participants |
| Subjects taking Antiparkinson Medication Levodopa (Sinemet or Stalevo) | 20 Participants | 21 Participants | 22 Participants | 20 Participants | 83 Participants |
| Subjects taking Antiparkinson Medication MAO-B Inhibitor | 11 Participants | 12 Participants | 14 Participants | 12 Participants | 49 Participants |
| Time since PD diagnosis | 8.94 years STANDARD_DEVIATION 3.395 | 9.33 years STANDARD_DEVIATION 4.913 | 10.66 years STANDARD_DEVIATION 7.057 | 9.00 years STANDARD_DEVIATION 3.484 | 9.51 years STANDARD_DEVIATION 4.964 |
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 | 0 / 22 | 0 / 20 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 18 / 22 | 16 / 20 | 20 / 21 | 18 / 20 |
| serious Total, serious adverse events | 0 / 22 | 1 / 20 | 0 / 21 | 4 / 20 |
Outcome results
Primary
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Time frame: Baseline (Day 1) and Week 8
Population: Participants in the MITT population with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | -6.7 units on a scale | Standard Error 2.68 |
| ADS-5102 (260 mg) | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | -12.3 units on a scale | Standard Error 2.88 |
| ADS-5102 (340 mg) | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | -17.9 units on a scale | Standard Error 2.82 |
| ADS-5102 (420 mg) | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | -16.7 units on a scale | Standard Error 2.88 |
Comparison: 20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.p-value: 0.005195% CI: [-19.1, -3.5]ANCOVA
p-value: 0.013195% CI: [-17.8, -2.2]ANCOVA
p-value: 0.159595% CI: [-13.4, 2.2]ANCOVA
Secondary
Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.
Time frame: Baseline (Day 1) and Week 8
Population: MITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | 0.9 hours | Standard Error 0.76 |
| ADS-5102 (260 mg) | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | 4.1 hours | Standard Error 0.82 |
| ADS-5102 (340 mg) | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | 3.8 hours | Standard Error 0.79 |
| ADS-5102 (420 mg) | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | 3.6 hours | Standard Error 0.83 |
p-value: 0.007895% CI: [0.8, 5.2]ANCOVA
p-value: 0.017995% CI: [0.5, 5]ANCOVA
p-value: 0.00495% CI: [1.1, 5.5]ANCOVA
Secondary
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.
Time frame: Baseline (Day 1) and Week 8
Population: MITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | -0.25 units on a scale | Standard Error 0.267 |
| ADS-5102 (260 mg) | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | -0.06 units on a scale | Standard Error 0.289 |
| ADS-5102 (340 mg) | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | -0.55 units on a scale | Standard Error 0.28 |
| ADS-5102 (420 mg) | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | 0.00 units on a scale | Standard Error 0.287 |
p-value: 0.431495% CI: [-1.1, 0.5]ANCOVA
p-value: 0.522395% CI: [-0.5, 1]ANCOVA
p-value: 0.629895% CI: [-0.6, 1]ANCOVA
Secondary
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.
Time frame: Baseline (Day 1) and Week 8
Population: MITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | -1.9 units on a scale | Standard Error 1.19 |
| ADS-5102 (260 mg) | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | -4.4 units on a scale | Standard Error 1.26 |
| ADS-5102 (340 mg) | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | -7.1 units on a scale | Standard Error 1.24 |
| ADS-5102 (420 mg) | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | -8.3 units on a scale | Standard Error 1.26 |
p-value: 0.003895% CI: [-8.7, -1.7]ANCOVA
p-value: 0.000495% CI: [-9.8, -2.9]ANCOVA
p-value: 0.146995% CI: [-6, 0.9]ANCOVA
Secondary
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.
Time frame: Baseline (Day 1) and Week 8
Population: MITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | -1.2 units on a scale | Standard Error 3.08 |
| ADS-5102 (260 mg) | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | 0.0 units on a scale | Standard Error 3.22 |
| ADS-5102 (340 mg) | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | -3.4 units on a scale | Standard Error 3.31 |
| ADS-5102 (420 mg) | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | 0.5 units on a scale | Standard Error 3.23 |
p-value: 0.635595% CI: [-11.2, 6.9]ANCOVA
p-value: 0.705395% CI: [-7.2, 10.6]ANCOVA
p-value: 0.786295% CI: [-7.7, 10.1]ANCOVA
Secondary
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).
Time frame: Baseline (Day 1) and Week 8
Population: MITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Improvement | 1 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Worsening | 0 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Worsening | 1 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Improvement | 6 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Worsening | 0 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Improvement | 4 Participants |
| Placebo | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | No Change | 10 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Worsening | 0 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | No Change | 3 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Improvement | 5 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Worsening | 1 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Worsening | 0 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Improvement | 8 Participants |
| ADS-5102 (260 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Improvement | 2 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | No Change | 4 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Improvement | 7 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Improvement | 8 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Improvement | 1 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Worsening | 0 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Worsening | 0 Participants |
| ADS-5102 (340 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Worsening | 0 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Improvement | 5 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Worsening | 0 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Worsening | 2 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Moderate Improvement | 6 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Marked Improvement | 4 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Minimal Worsening | 0 Participants |
| ADS-5102 (420 mg) | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | No Change | 2 Participants |
p-value: 0.0036Cochran-Mantel-Haenszel
p-value: 0.2158Cochran-Mantel-Haenszel
p-value: 0.1042Cochran-Mantel-Haenszel