Safety and efficacy of ADS-5102 (amantadine) extended release capsules to improve walking in multiple sclerosis: A randomized, placebo-controlled, phase 2 trial

Background: Walking impairment causes disability and reduced quality of life in patients with multiple sclerosis (MS). Objective: Characterize the safety and efficacy of ADS-5102 (amantadine) extended release capsules, 274 mg administered once daily at bedtime in patients with MS with walking impair...

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Bibliographic Details
Published in:Multiple sclerosis 2019-04, Vol.25 (4), p.601-609
Main Authors: Cohen, Jeffrey A, Hunter, Samuel F, Brown, Theodore R, Gudesblatt, Mark, Thrower, Ben W, Llorens, Lily, Souza-Prien, Cindy J, Ruby, April E, Chernoff, David N, Patni, Rajiv
Format: Article
Language:English
Subjects:
Adult
Aged
Amantadine
Amantadine - administration & dosage
Amantadine - adverse effects
Amantadine - pharmacology
Cognition
Constipation
Delayed-Action Preparations
Dopamine Agents - administration & dosage
Dopamine Agents - adverse effects
Dopamine Agents - pharmacology
Double-Blind Method
Dyskinesias - drug therapy
Dyskinesias - etiology
Dyskinesias - physiopathology
Exercise Test
Fatigue
Female
Humans
Male
Middle Aged
Multiple sclerosis
Multiple Sclerosis - complications
Multiple Sclerosis - drug therapy
Multiple Sclerosis - physiopathology
Outcome Assessment, Health Care
Patients
Proof of Concept Study
Quality of life
Safety
Serotonin
Sleep disorders
Walking
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Summary:Background: Walking impairment causes disability and reduced quality of life in patients with multiple sclerosis (MS). Objective: Characterize the safety and efficacy of ADS-5102 (amantadine) extended release capsules, 274 mg administered once daily at bedtime in patients with MS with walking impairment. Methods: This randomized, double-blind, placebo-controlled, 4-week study was conducted at 14 trial sites in the United States. Study objectives included safety and tolerability of ADS-5102, and efficacy assessments (Timed 25-Foot Walk (T25FW), Timed Up and Go (TUG), 2-Minute Walk Test, and Multiple Sclerosis Walking Scale-12). Fatigue, depression, and cognition also were assessed. Results: A total of 60 patients were randomized (30 to ADS-5102 and 30 to placebo); 59 of whom were treated. The most frequent adverse events (AEs) were dry mouth, constipation, and insomnia. Five ADS-5102 patients and no placebo patients discontinued treatment due to AEs. One patient in the ADS-5102 group experienced a serious AE—suspected serotonin syndrome. A 16.6% placebo-adjusted improvement was seen in the T25FW test (p 
ISSN:1352-4585
1477-0970
DOI:10.1177/1352458518754716