Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
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ClinicalTrials.gov Identifier: NCT03436199 |
Recruitment Status :
Completed
First Posted : February 19, 2018
Last Update Posted : April 20, 2020
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Sponsor:
Adamas Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | February 12, 2018 | ||||
First Posted Date ICMJE | February 19, 2018 | ||||
Last Update Posted Date | April 20, 2020 | ||||
Actual Study Start Date ICMJE | March 29, 2018 | ||||
Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Timed 25 foot walk (T25FW, feet/second) [ Time Frame: 12 weeks ] The T25FW 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.
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Original Primary Outcome Measures ICMJE |
Efficacy of ADS-5102 in subjects with multiple sclerosis with walking impairment as measured by the T25FW, feet/second at Week 12 [ Time Frame: 12 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment | ||||
Official Title ICMJE | A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment | ||||
Brief Summary | This is a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine extended release [ER] capsules) in MS patients with walking impairment. ADS-5102 will be administered once daily at bed time. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
594 | ||||
Original Estimated Enrollment ICMJE |
540 | ||||
Actual Study Completion Date ICMJE | December 10, 2019 | ||||
Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03436199 | ||||
Other Study ID Numbers ICMJE | ADS-AMT-MS301 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Adamas Pharmaceuticals, Inc. | ||||
Study Sponsor ICMJE | Adamas Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Adamas Pharmaceuticals, Inc. | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |