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Methylphenidate in Myotonic Dystrophy Type 1

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ClinicalTrials.gov Identifier: NCT01421992
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Dystrophia Myotonica 1 Drug: Methylphenidate Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1
Study Start Date : June 2008
Primary Completion Date : August 2010
Study Completion Date : September 2010


Arm Intervention/treatment
Placebo Comparator: Arm 1: Methylphenidate versus baseline Drug: Methylphenidate
One Tablet of methylphenidate, 20 mg per day during 3 weeks
Other Name: Ritalin
Placebo Comparator: Arm 2: Placebo versus baseline
One table placebo per day during 3 week
Drug: Placebo
one tablet placebo per day during 3 weeks



Primary Outcome Measures :
  1. Change from baseline of excessive daytime sleepiness [ Time Frame: 3 weeks after treatment ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421992


Locations
Canada
Institute of Readaptation in Physical Deficiency
Quebec, Canada, G1M2S8
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Jack J Puymirat, MD University Laval

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01421992     History of Changes
Other Study ID Numbers: AFM-12117
AFM-12117 ( Other Grant/Funding Number: AFM-12117 )
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: June 2011

Keywords provided by Laval University:
randomized
double-blind
crossover
methylphenidate
excessive daytime sleepiness

Additional relevant MeSH terms:
Myotonic Dystrophy
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Myotonic Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents