NCT01421992|CompletedPhase 2/3
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
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Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · AFM-12117
interventional
28
1 country
1
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
September 2010
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 2010
Actual (reported)September 2010
Actual (reported)June 1, 2011
Actual (reported)August 23, 2011
Actual (reported)Change from baseline of excessive daytime sleepiness
3 weeks after treatment
Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency
3 weeks after treatment
One table placebo per day during 3 week
One Tablet of methylphenidate, 20 mg per day during 3 weeks
one tablet placebo per day during 3 weeks
Institute of Readaptation in Physical Deficiency
Québec, Quebec, G1M2S8, Canada
Annane D, Laberge L, Gallais B, Chevret S. Psychostimulants for hypersomnia (excessive daytime sleepiness) in myotonic dystrophy. Cochrane Database Syst Rev. 2024 Nov 18;11(11):CD003218. doi: 10.1002/14651858.CD003218.pub3.
Puymirat J, Bouchard JP, Mathieu J. Efficacy and tolerability of a 20-mg dose of methylphenidate for the treatment of daytime sleepiness in adult patients with myotonic dystrophy type 1: a 2-center, randomized, double-blind, placebo-controlled, 3-week crossover trial. Clin Ther. 2012 May;34(5):1103-11. doi: 10.1016/j.clinthera.2012.03.060.
Jack J Puymirat, MD
University Laval
28 participants (actual enrollment reported by the registry).
First Submitted
June 1, 2011
First Posted
August 23, 2011
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2010
Actual (reported)Study Completion
September 2010
Actual (reported)Last Updated
August 23, 2011
Record last verified: 2011-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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