NCT01421992

Methylphenidate in Myotonic Dystrophy Type 1

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dystrophia Myotonica 1

Interventions

Type	Name	Description
DRUG	Methylphenidate	One Tablet of methylphenidate, 20 mg per day during 3 weeks
DRUG	Placebo	one tablet placebo per day during 3 weeks

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2011-08-23
• Last updated: 2011-08-23

Locations

1 site across 1 country: Canada