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Completed

NCT Number: NCT01421992

Methylphenidate in Myotonic Dystrophy Type 1

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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Key information

Conditions

Dystrophia Myotonica 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Excessive Somnolence Dyssomnias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Readaptation in Physical Deficiency

Québec, Quebec, G1M2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults
  • Epworth score ≥ 10
  • Diagnosis of myotonic dystrophy type 1

Exclusion criteria

  • hypersensibility to methylphenidate
  • Pregnancy
  • Patients who receive drugs that interfere with methylphenidate
  • Cognitive impairment
  • Sleep apnea

Treatment and study plan

Methylphenidate

Drug

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

Other names: Ritalin

Placebo

Drug

one tablet placebo per day during 3 weeks

Primary outcomes

  1. Change from baseline of excessive daytime sleepiness

    Time frame: 3 weeks after treatment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2011
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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