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).
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.
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
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There are 92 Locations for this study
Cullman Alabama, 35058, United States
Phoenix Arizona, 85018, United States
Phoenix Arizona, 85032, United States
Tucson Arizona, 85704, United States
Carlsbad California, 92011, United States
Fresno California, 93710, United States
Fullerton California, 92835, United States
Long Beach California, 90806, United States
Newport Beach California, 92663, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80020, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
New London Connecticut, 06320, United States
Washington District of Columbia, 20007, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Naples Florida, 34105, United States
Orlando Florida, 32806, United States
Ormond Beach Florida, 32174, United States
Palm Coast Florida, 32164, United States
Port Charlotte Florida, 33952, United States
Saint Petersburg Florida, 33713, United States
Sarasota Florida, 34233, United States
Tampa Florida, 33609, United States
Vero Beach Florida, 32960, United States
Atlanta Georgia, 30309, United States
Savannah Georgia, 31406, United States
Northbrook Illinois, 60062, United States
Indianapolis Indiana, 46256, United States
Kansas City Kansas, 66103, United States
Lenexa Kansas, 66214, United States
Overland Park Kansas, 66212, United States
Burlington Massachusetts, 01805, United States
Foxboro Massachusetts, 02035, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 42801, United States
Farmington Hills Michigan, 48334, United States
Golden Valley Minnesota, 55422, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Great Falls Montana, 59405, United States
Lincoln Nebraska, 68506, United States
Omaha Nebraska, 68105, United States
Las Vegas Nevada, 89106, United States
Albuquerque New Mexico, 87106, United States
Amherst New York, 14226, United States
Lake Success New York, 11042, United States
New York New York, 10029, United States
Patchogue New York, 11772, United States
Plainview New York, 11803, United States
Rochester New York, 14642, United States
Staten Island New York, 10306, United States
Charlotte North Carolina, 28204, United States
Raleigh North Carolina, 27607, United States
Centerville Ohio, 45459, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19140, United States
Charleston South Carolina, 29406, United States
Greer South Carolina, 29650, United States
Rock Hill South Carolina, 29732, United States
Spartanburg South Carolina, 29307, United States
Cordova Tennessee, 38018, United States
Franklin Tennessee, 37064, United States
Johnson City Tennessee, 37604, United States
Houston Texas, 77030, United States
Houston Texas, 77074, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
Salt Lake City Utah, 84103, United States
Newport News Virginia, 23601, United States
Norfolk Virginia, 23502, United States
Kirkland Washington, 98034, United States
Seattle Washington, 98122, United States
Seattle Washington, 98191, United States
Milwaukee Wisconsin, 53215, United States
Edmonton Alberta, T6G 2, Canada
Lethbridge Alberta, T1J 0, Canada
Burnaby Brithis Columbia, V5G 2, Canada
Vancouver British Columbia, V6T 2, Canada
Hamilton Ontario, L8L 2, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Greenfield Park Quebec, J4V 2, Canada
Montréal Quebec, H3A 2, Canada
Québec City Quebec, G1J 1, Canada
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