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Methylphenidate in Myotonic Dystrophy Type 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01421992
First received: June 1, 2011
Last updated: August 22, 2011
Last verified: June 2011
History of Changes

June 1, 2011
August 22, 2011
June 2008
August 2010   (final data collection date for primary outcome measure)
Change from baseline of excessive daytime sleepiness [ Time Frame: 3 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01421992 on ClinicalTrials.gov Archive Site
Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency [ Time Frame: 3 weeks after treatment ] [ Designated as safety issue: No ]
Mean sleep latency was measured using the behavioural Osler's test
Same as current
Not Provided
Not Provided
 
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

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).

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dystrophia Myotonica 1
  • Drug: Methylphenidate
    One Tablet of methylphenidate, 20 mg per day during 3 weeks
    Other Name: Ritalin
  • Drug: Placebo
    one tablet placebo per day during 3 weeks
  • Placebo Comparator: Arm 1: Methylphenidate versus baseline
    Intervention: Drug: Methylphenidate
  • Placebo Comparator: Arm 2: Placebo versus baseline
    One table placebo per day during 3 week
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01421992
AFM-12117, AFM-12117
No
Laval University
Laval University
Not Provided
Principal Investigator: Jack J Puymirat, MD University Laval
Laval University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP