- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421992
Methylphenidate in Myotonic Dystrophy Type 1
August 22, 2011 updated by: Laval University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
28
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Quebec, Canada, G1M2S8
- Institute of Readaptation in Physical Deficiency
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Arm 1: Methylphenidate versus baseline
|
One Tablet of methylphenidate, 20 mg per day during 3 weeks
Other Names:
|
Placebo Comparator: Arm 2: Placebo versus baseline
One table placebo per day during 3 week
|
one tablet placebo per day during 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline of excessive daytime sleepiness
Time Frame: 3 weeks after treatment
|
3 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jack J Puymirat, MD, University Laval
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
August 22, 2011
First Posted (Estimate)
August 23, 2011
Study Record Updates
Last Update Posted (Estimate)
August 23, 2011
Last Update Submitted That Met QC Criteria
August 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Muscular Disorders, Atrophic
- Heredodegenerative Disorders, Nervous System
- Muscular Dystrophies
- Myotonic Disorders
- Myotonic Dystrophy
- Disorders of Excessive Somnolence
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- AFM-12117 (Other Grant/Funding Number: AFM-12117)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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