Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Public ClinicalTrials.gov record NCT02471222. 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
Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
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 of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.
Study identification
- NCT ID
- NCT02471222
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Apr 30, 2015
- Primary completion
- May 31, 2016
- Completion
- May 31, 2016
- Last update posted
- Aug 7, 2017
2015 – 2016
United States locations
- U.S. sites
- 15
- U.S. states
- 15
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85018 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | Atlanta | Georgia | 30309 | — |
| Not listed | Northbrook | Illinois | 60062 | — |
| Not listed | Rochester | Minnesota | 55905 | — |
| Not listed | Lincoln | Nebraska | 68506 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | Patchogue | New York | 11772 | — |
| Not listed | Raleigh | North Carolina | 27607 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Franklin | Tennessee | 37064 | — |
| Not listed | Dallas | Texas | 75214 | — |
| Not listed | Kirkland | Washington | 11772 | — |
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 NCT02471222, 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 Aug 7, 2017 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02471222 live on ClinicalTrials.gov.