Multiple Sclerosis Clinical Trial

A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

Summary

This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

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Full Description

This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.

All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.

Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.

All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Signed a current IRB-approved informed consent form
Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

Exclusion Criteria:

Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
If female, is pregnant or lactating
If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from baseline through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.
Anticipated treatment with any amantadine formulation other than ADS-5102
Planned participation in another interventional clinical trial

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

424

Study ID:

NCT03567057

Recruitment Status:

Completed

Sponsor:

Adamas Pharmaceuticals, Inc.

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There are 92 Locations for this study

See Locations Near You

Adamas Clinical Site
Cullman Alabama, 35058, United States
Adamas Clinical Site
Phoenix Arizona, 85018, United States
Adamas Clinical Site
Phoenix Arizona, 85032, United States
Adamas Clinical Site
Tucson Arizona, 85704, United States
Adamas Clinical Site
Carlsbad California, 92011, United States
Adamas Clinical Site
Fresno California, 93710, United States
Adamas Clinical Site
Fullerton California, 92835, United States
Adamas Clinical Site
Long Beach California, 90806, United States
Adamas Clinical Site
Newport Beach California, 92663, United States
Adamas Clinical Site
Sacramento California, 95817, United States
Adamas Clinical Site
Aurora Colorado, 80045, United States
Adamas Clinical Site
Colorado Springs Colorado, 80907, United States
Adamas Clinical Site
Denver Colorado, 80020, United States
Adamas Clinical Site
Fort Collins Colorado, 80528, United States
Adamas Clinical Site
Fairfield Connecticut, 06824, United States
Adamas Clinical Site
New London Connecticut, 06320, United States
Adamas Clinical Site
Washington District of Columbia, 20007, United States
Adamas Clinical Site
Maitland Florida, 32751, United States
Adamas Clinical Site
Miami Florida, 33136, United States
Adamas Clinical Site
Miami Florida, 33176, United States
Adamas Clinical Site
Naples Florida, 34105, United States
Adamas Clinical Site
Orlando Florida, 32806, United States
Adamas Clinical Site
Ormond Beach Florida, 32174, United States
Adamas Clinical Site
Palm Coast Florida, 32164, United States
Adamas Clinical Site
Port Charlotte Florida, 33952, United States
Adamas Clinical Site
Saint Petersburg Florida, 33713, United States
Adamas Clinical Site
Sarasota Florida, 34233, United States
Adamas Clinical Site
Tampa Florida, 33609, United States
Adamas Clinical Site
Vero Beach Florida, 32960, United States
Adamas Clinical Site
Atlanta Georgia, 30309, United States
Adamas Clinical Site
Savannah Georgia, 31406, United States
Adamas Clinical Site
Northbrook Illinois, 60062, United States
Adamas Clinical Site
Indianapolis Indiana, 46256, United States
Adamas Clinical Site
Kansas City Kansas, 66103, United States
Adamas Clinical Site
Lenexa Kansas, 66214, United States
Adamas Clinical Site
Overland Park Kansas, 66212, United States
Adamas Clinical Site
Burlington Massachusetts, 01805, United States
Adamas Clinical Site
Foxboro Massachusetts, 02035, United States
Adamas Clinical Site
Worcester Massachusetts, 01655, United States
Adamas Clinical Site
Detroit Michigan, 42801, United States
Adamas Clinical Site
Farmington Hills Michigan, 48334, United States
Adamas Clinical Site
Golden Valley Minnesota, 55422, United States
Adamas Clinical Site
Kansas City Missouri, 64111, United States
Adamas Clinical Site
Saint Louis Missouri, 63110, United States
Adamas Clinical Site
Great Falls Montana, 59405, United States
Adamas Clinical Site
Lincoln Nebraska, 68506, United States
Adamas Clinical Site
Omaha Nebraska, 68105, United States
Adamas Clinical Site
Las Vegas Nevada, 89106, United States
Adamas Clinical Site
Albuquerque New Mexico, 87106, United States
Adamas Clinical Site
Amherst New York, 14226, United States
Adamas Clinical Site
Lake Success New York, 11042, United States
Adamas Clinical Site
New York New York, 10029, United States
Adamas Clinical Site
Patchogue New York, 11772, United States
Adamas Clinical Site
Plainview New York, 11803, United States
Adamas Clinical Site
Rochester New York, 14642, United States
Adamas Clinical Site
Staten Island New York, 10306, United States
Adamas Clinical Site
Charlotte North Carolina, 28204, United States
Adamas Clinical Site
Raleigh North Carolina, 27607, United States
Adamas Clinical Site
Centerville Ohio, 45459, United States
Adamas Clinical Site
Cleveland Ohio, 44195, United States
Adamas Clinical Site
Columbus Ohio, 43214, United States
Adamas Clinical Site
Oklahoma City Oklahoma, 73104, United States
Adamas Clinical Site
Portland Oregon, 97213, United States
Adamas Clinical Site
Philadelphia Pennsylvania, 19140, United States
Adamas Clinical Site
Charleston South Carolina, 29406, United States
Adamas Clinical Site
Greer South Carolina, 29650, United States
Adamas Clinical Site
Rock Hill South Carolina, 29732, United States
Adamas Clinical Site
Spartanburg South Carolina, 29307, United States
Adamas Clinical Site
Cordova Tennessee, 38018, United States
Adamas Clinical Site
Franklin Tennessee, 37064, United States
Adamas Clinical Site
Johnson City Tennessee, 37604, United States
Adamas Clinical Site
Houston Texas, 77030, United States
Adamas Clinical Site
Houston Texas, 77074, United States
Adamas Clinical Site
Lubbock Texas, 79410, United States
Adamas Clinical Site
Round Rock Texas, 78681, United States
Adamas Clinical Site
Salt Lake City Utah, 84103, United States
Adamas Clinical Site
Newport News Virginia, 23601, United States
Adamas Clinical Site
Norfolk Virginia, 23502, United States
Adamas Clinical Site
Kirkland Washington, 98034, United States
Adamas Clinical Site
Seattle Washington, 98122, United States
Adamas Clinical Site
Seattle Washington, 98191, United States
Adamas Clinical Site
Milwaukee Wisconsin, 53215, United States
Adamas Clinical Site
Edmonton Alberta, T6G 2, Canada
Adamas Clinical Site
Lethbridge Alberta, T1J 0, Canada
Adamas Clinical Site
Burnaby Brithis Columbia, V5G 2, Canada
Adamas Clinical Site
Vancouver British Columbia, V6T 2, Canada
Adamas Clinical Site
Hamilton Ontario, L8L 2, Canada
Adamas Clinical Site
London Ontario, N6A 5, Canada
Adamas Clinical Site
Ottawa Ontario, K1H 8, Canada
Adamas Clinical Site
Greenfield Park Quebec, J4V 2, Canada
Adamas Clinical Site
Montréal Quebec, H3A 2, Canada
Adamas Clinical Site
Québec City Quebec, G1J 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

424

Study ID:

NCT03567057

Recruitment Status:

Completed

Sponsor:


Adamas Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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