Trial · NCT02202551
Open-Label Safety Study of ADS-5102 in PD Patients With LID
NCT02202551, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety Study of ADS-5102 in PD Patients With LID. Trials, record NCT02202551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02202551
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety Study of ADS-5102 in PD Patients With LID
- NCT number
- NCT02202551
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 223 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease (PD)
- Interventions
- ADS-5102
- First posted
- 2014-07-29
- Last updated
- 2020-10-06
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Up to 101 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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). | units on a scale | MEAN | |
| SECONDARY | 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). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1a | AE | 57 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1P | AE | 70 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 2 | AE | 23 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 3 | AE | 55 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1a | Study drug-related AE | 31 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1P | Study drug-related AE | 45 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 2 | Study drug-related AE | 16 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 3 | Study drug-related AE | 32 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1a | SAEs | 16 | Participants | |
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | Group 1P | SAEs | 21 | Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1a | 60 | |
| Overall Study | STARTED | Group 1P | 78 | |
| Overall Study | STARTED | Group 2 | 24 | |
| Overall Study | STARTED | Group 3 | 61 | |
| Overall Study | COMPLETED | Group 1a | 35 | |
| Overall Study | COMPLETED | Group 1P | 41 | |
| Overall Study | COMPLETED | Group 2 | 14 | |
| Overall Study | COMPLETED | Group 3 | 39 | |
| Overall Study | NOT COMPLETED | Group 1a | 25 | |
| Overall Study | NOT COMPLETED | Group 1P | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events408
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fall | Injury, poisoning and procedural complications | Group 1a | 13 | 60 | |
| other | Fall | Injury, poisoning and procedural complications | Group 1P | 29 | 78 | |
| other | Fall | Injury, poisoning and procedural complications | Group 2 | 8 | 24 | |
| other | Fall | Injury, poisoning and procedural complications | Group 3 | 23 | 61 | |
| other | Hallucination (pooled) | Psychiatric disorders | Group 1a | 15 | 60 | |
| other | Hallucination (pooled) | Psychiatric disorders | Group 1P | 24 | 78 | |
| other | Hallucination (pooled) | Psychiatric disorders | Group 2 | 5 | 24 | |
| other | Hallucination (pooled) | Psychiatric disorders | Group 3 | 10 | 61 | |
| other | Hallucination, visual | Psychiatric disorders | Group 1a | 14 | 60 | |
| other | Hallucination, visual | Psychiatric disorders | Group 1P | 24 | 78 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1a | 4 | 60 |
| Total, all-cause mortality | Group 1P | 2 | 78 |
| Total, all-cause mortality | Group 2 | 2 | 24 |
| Total, all-cause mortality | Group 3 | 1 | 61 |
| Total, other adverse events | Group 1a | 47 | 60 |
| Total, other adverse events | Group 1P | 61 | 78 |
| Total, other adverse events | Group 2 | 21 | 24 |
| Total, other adverse events | Group 3 | 45 | 61 |
| Total, serious adverse events | Group 1a | 16 | 60 |
| Total, serious adverse events | Group 1P | 21 | 78 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers29
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02202551
GET https://conductscience.org/api/trials/v1/NCT02202551/results?page=2