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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADS-5102 (amantadine HCl extended release) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADS-5102 | Drug | Oral capsules to be administered once daily at bedtime for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25 Foot Walk | Up to 4 weeks | |
| Timed Up and go | Up to 4 weeks | |
| 2 Minute Walk Test |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Scale for Motor and Cognitive Functions | Up to 4 weeks | |
| Beck's Depression Inventory-2 | Up to 4 weeks | |
| Brief International Cognitive Assessment for MS |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85018 | United States | |||
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| Placebo | Other | Oral capsules to be administered once daily at bedtime for 4 weeks |
|
| Up to 4 weeks |
| MS Walking Scale-12 | Up to 4 weeks |
| Up to 4 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Sarasota | Florida | 34239 | United States |
| Atlanta | Georgia | 30309 | United States |
| Northbrook | Illinois | 60062 | United States |
| Rochester | Minnesota | 55905 | United States |
| Lincoln | Nebraska | 68506 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Patchogue | New York | 11772 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Cleveland | Ohio | 44195 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Franklin | Tennessee | 37064 | United States |
| Dallas | Texas | 75214 | United States |
| Kirkland | Washington | 11772 | United States |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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