Dystrophia Myotonica 1
Conditions
Keywords
randomized, double-blind, crossover, methylphenidate, excessive daytime sleepiness
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).
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.
Interventions
DRUGMethylphenidate
One Tablet of methylphenidate, 20 mg per day during 3 weeks
DRUGPlacebo
one tablet placebo per day during 3 weeks
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of excessive daytime sleepiness | 3 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency | 3 weeks after treatment | Mean sleep latency was measured using the behavioural Osler's test |
Countries
Canada
Outcome results
None listed