At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 28 enrolled
Drug / intervention
Methylphenidate +1 moredrug
Likely dose
Methylphenidate 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1
In Brief
A Phase 3 clinical trial evaluating Methylphenidate and Placebo for Dystrophia Myotonica 1. Completed, enrolled 28 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDystrophia Myotonica 1
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
Primary CompletionAug 2010
Study CompletionSep 2010
First PostedAug 2011
TodayJul 2026
First PostedAug 23, 2011
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.9 years ago
Interventions
Methylphenidatedrug
One Tablet of methylphenidate, 20 mg per day during 3 weeks
Placebodrug
one tablet placebo per day during 3 weeks