Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
This study is currently recruiting participants.
Verified June 2012 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
Richard T Moxley, University of Rochester
ClinicalTrials.gov Identifier:
NCT01406873
First received: July 20, 2011
Last updated: June 19, 2012
Last verified: June 2012
Tracking Information | |||||
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First Received Date ICMJE | July 20, 2011 | ||||
Last Updated Date | June 19, 2012 | ||||
Start Date ICMJE | June 2011 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Ambulation [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406873 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1 | ||||
Official Title ICMJE | A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type-1 (DM1) | ||||
Brief Summary | The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1). |
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Detailed Description | This study will provide data on the long term (6 months) safety and efficacy of mexiletine in:
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Myotonic Dystrophy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | October 2014 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406873 | ||||
Other Study ID Numbers ICMJE | 3716 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Richard T Moxley, University of Rochester | ||||
Study Sponsor ICMJE | University of Rochester | ||||
Collaborators ICMJE | FDA Office of Orphan Products Development | ||||
Investigators ICMJE |
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Information Provided By | University of Rochester | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |