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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
One Tablet of methylphenidate, 20 mg per day during 3 weeks
one tablet placebo per day during 3 weeks
Institute of Readaptation in Physical Deficiency
Québec, Quebec, Canada
Change from baseline of excessive daytime sleepiness
Time frame: 3 weeks after treatment
Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency
Mean sleep latency was measured using the behavioural Osler's test
Time frame: 3 weeks after treatment
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