Trial · NCT02274766
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
NCT02274766, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2018-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia. Trials, record NCT02274766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02274766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
- NCT number
- NCT02274766
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 77 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Dyskinesia, Levodopa-Induced Dyskinesia (LID), Parkinson's Disease (PD)
- Interventions
- ADS-5102, Placebo
- First posted
- 2014-10-24
- Last updated
- 2018-01-10
- Results first posted
- 2018-01-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score | Baseline to Week 12 | 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. |
| Secondary | Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Baseline to Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score | Baseline to Week 12 | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Baseline to Week 12 | MITT population | hours | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score | Placebo | -6.3 | Standard Error 2.08 | units on a scale | |
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score | ADS-5102 (Amantadine HCl Extended Release) | -20.7 | Standard Error 2.20 | units on a scale | |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in ON time without troublesome dyskinesia | 2.05 | Standard Error 0.526 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (Amantadine HCl Extended Release) | Change in ON time without troublesome dyskinesia | 3.95 | Standard Error 0.562 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in ON time with troublesome dyskinesia | -2.47 | Standard Error 0.436 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (Amantadine HCl Extended Release) | Change in ON time with troublesome dyskinesia | -3.61 | Standard Error 0.468 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in OFF time | 0.61 | Standard Error 0.313 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (Amantadine HCl Extended Release) | Change in OFF time | -0.49 | Standard Error 0.336 | hours |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | STARTED | ADS-5102 (Amantadine HCl Extended Release) | 38 | |
| Overall Study | Received Study Drug | Placebo | 38 | |
| Overall Study | Received Study Drug | ADS-5102 (Amantadine HCl Extended Release) | 37 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | COMPLETED | ADS-5102 (Amantadine HCl Extended Release) | 29 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | ADS-5102 (Amantadine HCl Extended Release) | 9 |
Source ClinicalTrials.gov
Adverse events178
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 | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 38 | |
| other | Dry mouth | Gastrointestinal disorders | ADS-5102 (Amantadine HCl Extended Release) | 5 | 37 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 38 | |
| other | Nausea | Gastrointestinal disorders | ADS-5102 (Amantadine HCl Extended Release) | 5 | 37 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 0 | 38 | |
| other | Decreased appetite | Metabolism and nutrition disorders | ADS-5102 (Amantadine HCl Extended Release) | 4 | 37 | |
| other | Insomnia | Psychiatric disorders | Placebo | 0 | 38 | |
| other | Insomnia | Psychiatric disorders | ADS-5102 (Amantadine HCl Extended Release) | 4 | 37 | |
| other | Orthostatic hypotension | Vascular disorders | Placebo | 0 | 38 | |
| other | Orthostatic hypotension | Vascular disorders | ADS-5102 (Amantadine HCl Extended Release) | 4 | 37 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, all-cause mortality | ADS-5102 (Amantadine HCl Extended Release) | 0 | 37 |
| Total, other adverse events | Placebo | 19 | 38 |
| Total, other adverse events | ADS-5102 (Amantadine HCl Extended Release) | 31 | 37 |
| Total, serious adverse events | Placebo | 0 | 38 |
| Total, serious adverse events | ADS-5102 (Amantadine HCl Extended Release) | 4 | 37 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ADS-5102 (Amantadine HCl Extended Release) vs Placebo: deaths from any cause | Trial comparisons |
| ADS-5102 (Amantadine HCl Extended Release) vs Placebo: serious adverse events | Trial comparisons |
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/NCT02274766
GET https://conductscience.org/api/trials/v1/NCT02274766/events?page=2