A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03567057|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Walking Impairment||Drug: ADS-5102||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||March 2021|
Oral capsules to be administered once daily at bedtime for the 52-week open-label treatment period.
Other Name: amantadine extended release
- Incidence of adverse events (safety and tolerability) of ADS-5102 in subjects with MS [ Time Frame: Through study completion, an average of 1 year. ]The primary outcome measure will be a tabulation of the treatment emergent adverse events.
- Timed 25-Foot Walk [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]The Timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as time to complete (seconds) or speed (feet per second). Improvement is indicated by a decrease in time or an increase in speed.
- Timed up and go [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
- 2-Minute Walk Test [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567057
|Study Director:||Clinical Trials Chief Medical Officer, MD||Adamas Pharmaceuticals, Inc.|