Methylphenidate in Myotonic Dystrophy Type 1

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01421992
• Date of registration: 01/06/2011
• Prospective Registration: No
• Primary sponsor: Laval University
• Public title: Methylphenidate in Myotonic Dystrophy Type 1
• Scientific title: Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1
• Date of first enrolment: June 2008
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01421992
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Jack J Puymirat, MD
• Affiliation: University Laval

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dystrophia Myotonica 1

Intervention(s)

Drug: Methylphenidate

Drug: Placebo

Primary Outcome(s)

Change from baseline of excessive daytime sleepiness [Time Frame: 3 weeks after treatment]

Secondary Outcome(s)

Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency [Time Frame: 3 weeks after treatment]

Secondary ID(s)

AFM-12117

Source(s) of Monetary Support

Please refer to primary and secondary sponsors