Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Public ClinicalTrials.gov record NCT02274766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
Study identification
- NCT ID
- NCT02274766
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 77 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 30 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2014 (Type not available)
- Primary completion
- Mar 10, 2016 (Actual)
- Completion
- Mar 10, 2016 (Actual)
- Last update posted
- Jan 10, 2018
2014 – 2016
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Sunnyvale | California | 94085 | — |
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Jacksonville | Florida | 32209 | — |
| Not listed | Port Charlotte | Florida | 33980 | — |
| Not listed | Sunrise | Florida | 33351 | — |
| Not listed | Tampa | Florida | 33612 | — |
| Not listed | Atlanta | Georgia | 30329 | — |
| Not listed | Chicago | Illinois | 60611 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Baltimore | Maryland | 21287 | — |
| Not listed | Elkridge | Maryland | 21075 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | West Bloomfield | Michigan | 48322 | — |
| Not listed | Greensboro | North Carolina | 27405 | — |
| Not listed | Raleigh | North Carolina | 27607 | — |
| Not listed | Tulsa | Oklahoma | 74136 | — |
| Not listed | Roanoke | Virginia | 24018 | — |
| Not listed | Kirkland | Washington | 98034 | — |
| Not listed | Morgantown | West Virginia | 26506 | — |
| Not listed | Milwaukee | Wisconsin | 53233 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02274766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02274766 live on ClinicalTrials.gov.