Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Public ClinicalTrials.gov record NCT01397422. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily 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) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
Study identification
- NCT ID
- NCT01397422
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 83 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
- Jul 2011 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Dec 13, 2017
2011 – 2013
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Sun City | Arizona | — | — |
| Not listed | Fountain Valley | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Oxnard | California | — | — |
| Not listed | Pasadena | California | — | — |
| Not listed | Reseda | California | — | — |
| Not listed | Sunnyvale | California | — | — |
| Not listed | Ventura | California | — | — |
| Not listed | Fairfield | Connecticut | — | — |
| Not listed | Boca Raton | Florida | — | — |
| Not listed | Bradenton | Florida | — | — |
| Not listed | Port Charlotte | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Augusta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Winfield | Illinois | — | — |
| Not listed | Des Moines | Iowa | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | West Bloomfield | Michigan | — | — |
| Not listed | Toms River | New Jersey | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Tulsa | Oklahoma | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Kirkland | Washington | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01397422, 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 Dec 13, 2017 · 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 NCT01397422 live on ClinicalTrials.gov.