Methylphenidate in Myotonic Dystrophy Type 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-09-30

Brief Summary

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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).

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Detailed Description

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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

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Dystrophia Myotonica 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1: Methylphenidate versus baseline

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

One Tablet of methylphenidate, 20 mg per day during 3 weeks

Arm 2: Placebo versus baseline

One table placebo per day during 3 week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

one tablet placebo per day during 3 weeks

Interventions

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