Methylphenidate in Myotonic Dystrophy Type 1
- Registration Number
- NCT01421992
- Lead Sponsor
- Laval University
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- adults
- Epworth score ≥ 10
- Diagnosis of myotonic dystrophy type 1
- hypersensibility to methylphenidate
- Pregnancy
- Patients who receive drugs that interfere with methylphenidate
- Cognitive impairment
- Sleep apnea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1: Methylphenidate versus baseline Methylphenidate - Arm 2: Placebo versus baseline Placebo One table placebo per day during 3 week
- Primary Outcome Measures
Name Time Method Change from baseline of excessive daytime sleepiness 3 weeks after treatment
- Secondary Outcome Measures
Name Time Method Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency 3 weeks after treatment Mean sleep latency was measured using the behavioural Osler's test
Trial Locations
- Locations (1)
Institute of Readaptation in Physical Deficiency
🇨🇦Quebec, Canada