Clinical Trial: Methylphenidate in Myotonic Dystrophy Type 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1

Brief Summary: The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).

Detailed Summary: Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by muscle weakness, myotonia, and the involvement of several systems. Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities.The current investigation represents a prospective, double-blind, randomized, crossover, placebo-controlled study designed to evaluate the efficacy of methylphenidate for the treatment of excessive daytime sleepiness (EDS) in adults with DM1.
Sponsor: Laval University

Current Primary Outcome: Change from baseline of excessive daytime sleepiness [ Time Frame: 3 weeks after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency [ Time Frame: 3 weeks after treatment ]

Mean sleep latency was measured using the behavioural Osler's test


Original Secondary Outcome: Same as current

Information By: Laval University

Dates:
Date Received: June 1, 2011
Date Started: June 2008
Date Completion:
Last Updated: August 22, 2011
Last Verified: June 2011