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Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia (EASE LID 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274766
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dyskinesia
Levodopa-Induced Dyskinesia (LID)
Parkinson's Disease (PD)
Interventions Drug: ADS-5102
Other: Placebo
Enrollment 77
Recruitment Details 77 subjects with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 32 study sites in the United States, Germany, France, Spain, and Austria. The first subject was randomized on 23 October 2014 and the last subject completed on 10 March 2016.
Pre-assignment Details All randomized subjects who received ≥ 1 dose of study drug and provided ≥ 1 postbaseline efficacy assessment (75) were included in both the Safety Analysis Population and the Modified Intent-to-Treat (MITT) population (with 38 subjects in the placebo group and 37 in the ADS-5102 group).
Arm/Group Title Placebo ADS-5102 (Amantadine HCl Extended Release)
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 13 weeks 340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 13 weeks
Period Title: Overall Study
Started 39 38
Received Study Drug 38 37
Completed 35 29
Not Completed 4 9
Reason Not Completed
Withdrawal by Subject             3             6
Did Not Receive Study Drug             1             1
Subject Unwilling to Proceed             0             1
Adverse Event             0             1
Arm/Group Title Placebo ADS-5102 (Amantadine HCl Extended Release) Total
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 13 weeks 340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks Total of all reporting groups
Overall Number of Baseline Participants 38 37 75
Hide Baseline Analysis Population Description
Safety Analysis Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  39.5%
16
  43.2%
31
  41.3%
>=65 years
23
  60.5%
21
  56.8%
44
  58.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 75 participants
64.9  (9.08) 64.7  (9.66) 64.8  (9.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
Female
18
  47.4%
18
  48.6%
36
  48.0%
Male
20
  52.6%
19
  51.4%
39
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
Hispanic or Latino
0
   0.0%
5
  13.5%
5
   6.7%
Not Hispanic or Latino
38
 100.0%
32
  86.5%
70
  93.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
38
 100.0%
36
  97.3%
74
  98.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.7%
1
   1.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
United States
8
  21.1%
15
  40.5%
23
  30.7%
Europe
30
  78.9%
22
  59.5%
52
  69.3%
Unified Dyskinesia Rating Scale (UDysRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 37 participants 75 participants
Total Score 41.2  (10.32) 40.2  (13.06) 40.7  (11.68)
Total Objective Score (Parts III, IV) 15.9  (7.00) 18.1  (7.99) 17.0  (7.53)
[1]
Measure Description: The UDysRS is a dyskinesia rating scale that evaluates involuntary movements associated with PD; the UDysRS consists of the following sub-parts: IA, IB, IIA, IIB, III, and IV. The total score is the sum of all individual sub-parts, and scores for this measure can range from 0-104. The total objective score is the sum of Part III (which measures objective impairment) and Part IV (which measures objective disability), and scores for this measure can range from 0-44. For both the total score and total objective score, a higher score indicates more severe PD.
PD Home Diary   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 38 participants 37 participants 75 participants
ON time without troublesome dyskinesia 7.79  (3.249) 8.77  (2.457) 8.27  (2.909)
ON time with troublesome dyskinesia 6.02  (3.353) 4.71  (2.509) 5.37  (3.020)
OFF time 1.98  (1.687) 2.62  (2.015) 2.30  (1.871)
Asleep time 8.21  (1.643) 7.91  (1.502) 8.06  (1.572)
[1]
Measure Description:

A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.

Total time with dyskinesia includes ON time with non-troublesome and troublesome dyskinesia.

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 37 participants 75 participants
Part I 9.9  (4.86) 11.3  (5.87) 10.6  (5.39)
Part II 14.8  (6.06) 14.1  (6.15) 14.4  (6.07)
Part III 21.4  (10.22) 21.2  (9.24) 21.3  (9.68)
Combined Parts I, II, and III 46.1  (17.00) 46.6  (14.76) 46.3  (15.83)
Part IV 11.1  (2.40) 9.8  (2.78) 10.5  (2.66)
Part IV, Item 4.1 2.8  (0.94) 2.2  (0.81) 2.5  (0.92)
Part IV, Item 4.2 2.5  (0.51) 2.5  (0.61) 2.5  (0.55)
[1]
Measure Description: The MDS-UPDRS Parts I, II, III, and IV examined non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications, respectively. Each Part contains items/questions, each rated on a scale from 0 (normal) to 4 (severe). The range of total scores for each Part is as follows: Part I, 0-52; Part II, 0-52; Part III, 0-132; Part IV, 0-24. Combined Parts I, II, and III is the sum of scores from Parts I, II, and III and has a scale range of 0-236. Parts 4.1 and 4.2 each has a scale range of 0-4. Higher scores indicate more severe PD.
Time Since PD Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 75 participants
10.71  (4.265) 10.40  (5.105) 10.55  (4.669)
Duration of Levodopa Treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 75 participants
8.54  (4.845) 7.69  (4.121) 8.12  (4.493)
Duration of LID  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 75 participants
3.98  (2.566) 3.78  (3.160) 3.88  (2.857)
Hoehn and Yahr Stage   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 37 participants 75 participants
2.4  (0.55) 2.1  (0.60) 2.2  (0.59)
[1]
Measure Description: The Hoehn and Yahr scale, from 1-5, describes the subject's PD progression. The higher the score the more severe the symptoms of PD.
Subjects taking Antiparkinson Medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 75 participants
Levodopa
38
 100.0%
37
 100.0%
75
 100.0%
Dopamine Agonists
25
  65.8%
21
  56.8%
46
  61.3%
MAO Inhibitors
20
  52.6%
17
  45.9%
37
  49.3%
COMT Inhibitors
1
   2.6%
3
   8.1%
4
   5.3%
Anticholinergics
2
   5.3%
0
   0.0%
2
   2.7%
[1]
Measure Description: Subjects may have been taking more than 1 antiparkinson medication at Baseline.
1.Primary Outcome
Title Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score
Hide Description The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (Amantadine HCl Extended Release)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
Overall Number of Participants Analyzed 38 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.3  (2.08) -20.7  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (Amantadine HCl Extended Release)
Comments 32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear Mixed Model w/ Repeated Measures
Comments Change from baseline is a dependent variable; the baseline value is a continuous covariate
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-20.4 to -8.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Hide Description A PD home diary was used to score 5 different conditions in 30-minute 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 2, 4, 8, and 12 visits.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (Amantadine HCl Extended Release)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
Overall Number of Participants Analyzed 38 37
Least Squares Mean (Standard Error)
Unit of Measure: hours
Change in ON time without troublesome dyskinesia 2.05  (0.526) 3.95  (0.562)
Change in ON time with troublesome dyskinesia -2.47  (0.436) -3.61  (0.468)
Change in OFF time 0.61  (0.313) -0.49  (0.336)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (Amantadine HCl Extended Release)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0168
Comments Change from Baseline in ON time without troublesome dyskinesia.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
0.35 to 3.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.775
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ADS-5102 (Amantadine HCl Extended Release)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0853
Comments Change from Baseline in ON time with troublesome dyskinesia.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-2.42 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.648
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ADS-5102 (Amantadine HCl Extended Release)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0199
Comments Change from Baseline in OFF time.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-2.02 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.461
Estimation Comments [Not Specified]
Time Frame Baseline through Week 13
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ADS-5102 (Amantadine HCl Extended Release)
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 13 weeks 340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
All-Cause Mortality
Placebo ADS-5102 (Amantadine HCl Extended Release)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/37 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ADS-5102 (Amantadine HCl Extended Release)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   4/37 (10.81%) 
Cardiac disorders     
Cardio-respiratory arrest  1  0/38 (0.00%)  1/37 (2.70%) 
Gastrointestinal disorders     
Constipation  1  0/38 (0.00%)  1/37 (2.70%) 
Injury, poisoning and procedural complications     
Laceration  1  0/38 (0.00%)  1/37 (2.70%) 
Nervous system disorders     
Transient ischaemic attack  1  0/38 (0.00%)  1/37 (2.70%) 
Dysaesthesia  1  0/38 (0.00%)  1/37 (2.70%) 
Psychiatric disorders     
Suicide attempt  1  0/38 (0.00%)  1/37 (2.70%) 
Renal and urinary disorders     
Urinary retention  1  0/38 (0.00%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Placebo ADS-5102 (Amantadine HCl Extended Release)
Affected / at Risk (%) Affected / at Risk (%)
Total   19/38 (50.00%)   31/37 (83.78%) 
Cardiac disorders     
Arrhythmia  1  0/38 (0.00%)  1/37 (2.70%) 
Palpitations  1  1/38 (2.63%)  0/37 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/38 (2.63%)  1/37 (2.70%) 
Eye disorders     
Cataract  1  1/38 (2.63%)  1/37 (2.70%) 
Photophobia  1  0/38 (0.00%)  1/37 (2.70%) 
Vision blurred  1  1/38 (2.63%)  1/37 (2.70%) 
Vitreous floaters  1  1/38 (2.63%)  0/37 (0.00%) 
Visual impairement  1  0/38 (0.00%)  1/37 (2.70%) 
Gastrointestinal disorders     
Dry mouth  1  1/38 (2.63%)  5/37 (13.51%) 
Nausea  1  1/38 (2.63%)  5/37 (13.51%) 
Constipation  1  0/38 (0.00%)  2/37 (5.41%) 
Abdominal pain  1  1/38 (2.63%)  1/37 (2.70%) 
Abdominal pain upper  1  0/38 (0.00%)  1/37 (2.70%) 
Dyspepsia  1  0/38 (0.00%)  1/37 (2.70%) 
Vomiting  1  0/38 (0.00%)  1/37 (2.70%) 
Salivary hypersecretion  1  1/38 (2.63%)  0/37 (0.00%) 
Toothache  1  1/38 (2.63%)  0/37 (0.00%) 
General disorders     
Malaise  1  0/38 (0.00%)  2/37 (5.41%) 
Asthenia  1  2/38 (5.26%)  1/37 (2.70%) 
Gait disturbance  1  0/38 (0.00%)  1/37 (2.70%) 
Pain  1  0/38 (0.00%)  1/37 (2.70%) 
Hunger  1  1/38 (2.63%)  0/37 (0.00%) 
Oedema peripheral  1  1/38 (2.63%)  0/37 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  3/38 (7.89%)  2/37 (5.41%) 
Influenza  1  0/38 (0.00%)  1/37 (2.70%) 
Urinary tract infection  1  0/38 (0.00%)  1/37 (2.70%) 
Bronchitis  1  1/38 (2.63%)  0/37 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  2/38 (5.26%)  3/37 (8.11%) 
Craniocerebral injury  1  0/38 (0.00%)  1/37 (2.70%) 
Face injury  1  0/38 (0.00%)  1/37 (2.70%) 
Traumatic haematoma  1  0/38 (0.00%)  1/37 (2.70%) 
Injury  1  1/38 (2.63%)  0/37 (0.00%) 
Investigations     
Gamma-glutamyltransferase increased  1  0/38 (0.00%)  1/37 (2.70%) 
Weight increased  1  0/38 (0.00%)  1/37 (2.70%) 
Glomerular filtration rate decreased  1  1/38 (2.63%)  0/37 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/38 (0.00%)  4/37 (10.81%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/38 (0.00%)  2/37 (5.41%) 
Back pain  1  2/38 (5.26%)  1/37 (2.70%) 
Arthralgia  1  1/38 (2.63%)  1/37 (2.70%) 
Muscle rigidity  1  0/38 (0.00%)  1/37 (2.70%) 
Myalgia  1  0/38 (0.00%)  1/37 (2.70%) 
Pain in extremity  1  0/38 (0.00%)  1/37 (2.70%) 
Intervertebral disc protrusion  1  1/38 (2.63%)  0/37 (0.00%) 
Joint stiffness  1  1/38 (2.63%)  0/37 (0.00%) 
Nervous system disorders     
Dizziness  1  1/38 (2.63%)  2/37 (5.41%) 
Dystonia  1  0/38 (0.00%)  2/37 (5.41%) 
Headache  1  1/38 (2.63%)  2/37 (5.41%) 
Somnolence  1  0/38 (0.00%)  2/37 (5.41%) 
Freezing phenomenon  1  0/38 (0.00%)  1/37 (2.70%) 
Intracranial venous sinus thrombosis  1  0/38 (0.00%)  1/37 (2.70%) 
Paraesthesia  1  0/38 (0.00%)  1/37 (2.70%) 
Parkinson's disease  1  0/38 (0.00%)  1/37 (2.70%) 
Transverse sinus thrombosis  1  0/38 (0.00%)  1/37 (2.70%) 
Disturbance in attention  1  1/38 (2.63%)  0/37 (0.00%) 
Tremor  1  1/38 (2.63%)  0/37 (0.00%) 
Psychiatric disorders     
Insomnia  1  0/38 (0.00%)  4/37 (10.81%) 
Hallucination (Pooled)  1 [1]  2/38 (5.26%)  3/37 (8.11%) 
Apathy  1  0/38 (0.00%)  2/37 (5.41%) 
Depressed mood  1  0/38 (0.00%)  2/37 (5.41%) 
Affect lability  1  0/38 (0.00%)  1/37 (2.70%) 
Anxiety  1  1/38 (2.63%)  1/37 (2.70%) 
Mental status changes  1  0/38 (0.00%)  1/37 (2.70%) 
Middle insomnia  1  0/38 (0.00%)  1/37 (2.70%) 
Nervousness  1  0/38 (0.00%)  1/37 (2.70%) 
Suicidal ideation  1  0/38 (0.00%)  1/37 (2.70%) 
Confusional state  1  1/38 (2.63%)  0/37 (0.00%) 
Restlessness  1  1/38 (2.63%)  0/37 (0.00%) 
Renal and urinary disorders     
Dysuria  1  0/38 (0.00%)  1/37 (2.70%) 
Pollakiuria  1  0/38 (0.00%)  1/37 (2.70%) 
Nocturia  1  1/38 (2.63%)  0/37 (0.00%) 
Renal cyst  1  1/38 (2.63%)  0/37 (0.00%) 
Urinary incontinence  1  1/38 (2.63%)  0/37 (0.00%) 
Renal impairment  1  0/38 (0.00%)  1/37 (2.70%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/38 (0.00%)  2/37 (5.41%) 
Erectile dysfunction  1  0/38 (0.00%)  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/38 (0.00%)  2/37 (5.41%) 
Chronic obstructive pulmonary disease  1  1/38 (2.63%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/38 (0.00%)  1/37 (2.70%) 
Skin odour abnormal  1  0/38 (0.00%)  1/37 (2.70%) 
Vascular disorders     
Orthostatic hypotension  1  0/38 (0.00%)  4/37 (10.81%) 
Jugular vein thrombosis  1  0/38 (0.00%)  1/37 (2.70%) 
Peripheral coldness  1  0/38 (0.00%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
[1]
consisted of auditory (0/38 in placebo, 1/37 in ADS-5102) and visual (2/38 in placebo, 3/37 in ADS-5102)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head, Regulatory Affairs
Organization: Adamas Pharmaceuticals, Inc.
Phone: +1 (510) 450-3500
EMail: drugsafety@adamaspharma.com
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Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02274766     History of Changes
Other Study ID Numbers: ADS-AMT-PD304
First Submitted: October 22, 2014
First Posted: October 24, 2014
Results First Submitted: September 21, 2017
Results First Posted: January 10, 2018
Last Update Posted: January 10, 2018