A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
NCT ID: NCT03567057
Last Updated: 2022-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
424 participants
INTERVENTIONAL
2018-07-18
2021-04-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADS-5102, 274 mg
274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
ADS-5102, 274 mg
Oral capsules
Interventions
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ADS-5102, 274 mg
Oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Adamas Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Adamas Pharmaceuticals, Inc.
Locations
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Adamas Clinical Site
Cullman, Alabama, United States
Adamas Clinical Site
Phoenix, Arizona, United States
Adamas Clinical Site
Phoenix, Arizona, United States
Adamas Clinical Site
Tucson, Arizona, United States
Adamas Clinical Site
Carlsbad, California, United States
Adamas Clinical Site
Fresno, California, United States
Adamas Clinical Site
Fullerton, California, United States
Adamas Clinical Site
Long Beach, California, United States
Adamas Clinical Site
Newport Beach, California, United States
Adamas Clinical Site
Sacramento, California, United States
Adamas Clinical Site
Aurora, Colorado, United States
Adamas Clinical Site
Colorado Springs, Colorado, United States
Adamas Clinical Site
Denver, Colorado, United States
Adamas Clinical Site
Fort Collins, Colorado, United States
Adamas Clinical Site
Fairfield, Connecticut, United States
Adamas Clinical Site
New London, Connecticut, United States
Adamas Clinical Site
Washington D.C., District of Columbia, United States
Adamas Clinical Site
Maitland, Florida, United States
Adamas Clinical Site
Miami, Florida, United States
Adamas Clinical Site
Miami, Florida, United States
Adamas Clinical Site
Naples, Florida, United States
Adamas Clinical Site
Orlando, Florida, United States
Adamas Clinical Site
Ormond Beach, Florida, United States
Adamas Clinical Site
Palm Coast, Florida, United States
Adamas Clinical Site
Port Charlotte, Florida, United States
Adamas Clinical Site
Sarasota, Florida, United States
Adamas Clinical Site
St. Petersburg, Florida, United States
Adamas Clinical Site
Tampa, Florida, United States
Adamas Clinical Site
Vero Beach, Florida, United States
Adamas Clinical Site
Atlanta, Georgia, United States
Adamas Clinical Site
Savannah, Georgia, United States
Adamas Clinical Site
Northbrook, Illinois, United States
Adamas Clinical Site
Indianapolis, Indiana, United States
Adamas Clinical Site
Kansas City, Kansas, United States
Adamas Clinical Site
Lenexa, Kansas, United States
Adamas Clinical Site
Overland Park, Kansas, United States
Adamas Clinical Site
Burlington, Massachusetts, United States
Adamas Clinical Site
Foxborough, Massachusetts, United States
Adamas Clinical Site
Worcester, Massachusetts, United States
Adamas Clinical Site
Detroit, Michigan, United States
Adamas Clinical Site
Farmington Hills, Michigan, United States
Adamas Clinical Site
Golden Valley, Minnesota, United States
Adamas Clinical Site
Kansas City, Missouri, United States
Adamas Clinical Site
St Louis, Missouri, United States
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Great Falls, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Amherst, New York, United States
Adamas Clinical Site
Lake Success, New York, United States
Adamas Clinical Site
New York, New York, United States
Adamas Clinical Site
Patchogue, New York, United States
Adamas Clinical Site
Plainview, New York, United States
Adamas Clinical Site
Rochester, New York, United States
Adamas Clinical Site
Staten Island, New York, United States
Adamas Clinical Site
Charlotte, North Carolina, United States
Adamas Clinical Site
Raleigh, North Carolina, United States
Adamas Clinical Site
Centerville, Ohio, United States
Adamas Clinical Site
Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Cordova, Tennessee, United States
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Franklin, Tennessee, United States
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Johnson City, Tennessee, United States
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Houston, Texas, United States
Adamas Clinical Site
Houston, Texas, United States
Adamas Clinical Site
Lubbock, Texas, United States
Adamas Clinical Site
Round Rock, Texas, United States
Adamas Clinical Site
Salt Lake City, Utah, United States
Adamas Clinical Site
Newport News, Virginia, United States
Adamas Clinical Site
Norfolk, Virginia, United States
Adamas Clinical Site
Kirkland, Washington, United States
Adamas Clinical Site
Seattle, Washington, United States
Adamas Clinical Site
Seattle, Washington, United States
Adamas Clinical Site
Milwaukee, Wisconsin, United States
Adamas Clinical Site
Edmonton, Alberta, Canada
Adamas Clinical Site
Lethbridge, Alberta, Canada
Adamas Clinical Site
Burnaby, Brithis Columbia, Canada
Adamas Clinical Site
Vancouver, British Columbia, Canada
Adamas Clinical Site
Hamilton, Ontario, Canada
Adamas Clinical Site
London, Ontario, Canada
Adamas Clinical Site
Ottawa, Ontario, Canada
Adamas Clinical Site
Greenfield Park, Quebec, Canada
Adamas Clinical Site
Montreal, Quebec, Canada
Adamas Clinical Site
Québec, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ADS-AMT-MS303
Identifier Type: -
Identifier Source: org_study_id
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