Trial · NCT02136914
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
NCT02136914, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2018-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study). Trials, record NCT02136914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02136914
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
- NCT number
- NCT02136914
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease
- Interventions
- ADS-5102, Placebo
- First posted
- 2014-05-13
- Last updated
- 2018-02-06
- Results first posted
- 2018-02-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 | 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, 8, 12, 18, and 24. |
| Secondary | Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24 | Baseline to Week 24 | 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, 8, 12, 18, and 24. |
| Secondary | Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Baseline (BL) to Week 12 (W12) and Week 24 (W24) | 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, 8, 12, 18, and 24 visits. |
| Secondary | Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III) | Baseline (BL) to Week 12 (W12) and Week 24 (W24) | 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 contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD. |
| Secondary | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms | Baseline to Week 12 and Week 24 | 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). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 | Baseline to Week 12 | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24 | Baseline to Week 24 | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Baseline (BL) to Week 12 (W12) and Week 24 (W24) | MITT population | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III) | Baseline (BL) to Week 12 (W12) and Week 24 (W24) | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms | Baseline to Week 12 and Week 24 | MITT population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 | Placebo | -8.0 | Standard Error 1.64 | units on a scale | |
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 | ADS-5102 (340 mg) | -15.9 | Standard Error 1.62 | units on a scale | |
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24 | Placebo | -6.3 | Standard Error 1.94 | units on a scale | |
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24 | ADS-5102 (340 mg) | -15.6 | Standard Error 1.87 | units on a scale | |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in ON time w/o troublesome dyskinesia (W12) | 0.82 | Standard Error 0.432 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (340 mg) | Change in ON time w/o troublesome dyskinesia (W12) | 3.56 | Standard Error 0.434 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in ON time w/o troublesome dyskinesia (W24) | 1.37 | Standard Error 0.456 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (340 mg) | Change in ON time w/o troublesome dyskinesia (W24) | 3.59 | Standard Error 0.440 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | Placebo | Change in OFF time (W12) | 0.32 | Standard Error 0.263 | hours |
| Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) | ADS-5102 (340 mg) | Change in OFF time (W12) | -0.59 | Standard Error 0.265 | hours |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 63 | |
| Overall Study | STARTED | ADS-5102 (340 mg) | 63 | |
| Overall Study | Received Study Drug | Placebo | 60 | |
| Overall Study | Received Study Drug | ADS-5102 (340 mg) | 63 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | COMPLETED | ADS-5102 (340 mg) | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | ADS-5102 (340 mg) | 21 |
Source ClinicalTrials.gov
Adverse events60
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 | Hallucination, any type | Psychiatric disorders | Placebo | 1 | 60 | |
| other | Hallucination, any type | Psychiatric disorders | ADS-5102 (340 mg) | 18 | 63 | |
| other | Hallucination, visual | Psychiatric disorders | Placebo | 1 | 60 | |
| other | Hallucination, visual | Psychiatric disorders | ADS-5102 (340 mg) | 15 | 63 | |
| other | Hallucination, auditory | Psychiatric disorders | Placebo | 0 | 60 | |
| other | Hallucination, auditory | Psychiatric disorders | ADS-5102 (340 mg) | 5 | 63 | |
| other | Oedema peripheral | General disorders | Placebo | 0 | 60 | |
| other | Oedema peripheral | General disorders | ADS-5102 (340 mg) | 15 | 63 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 60 | |
| other | Dizziness | Nervous system disorders | ADS-5102 (340 mg) | 14 | 63 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 60 |
| Total, all-cause mortality | ADS-5102 (340 mg) | 1 | 63 |
| Total, other adverse events | Placebo | 36 | 60 |
| Total, other adverse events | ADS-5102 (340 mg) | 56 | 63 |
| Total, serious adverse events | Placebo | 3 | 60 |
| Total, serious adverse events | ADS-5102 (340 mg) | 7 | 63 |
Source ClinicalTrials.gov
Papers4
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 (340 mg) vs Placebo: deaths from any cause | Trial comparisons |
| ADS-5102 (340 mg) 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/NCT02136914
GET https://conductscience.org/api/trials/v1/NCT02136914/results?page=2