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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 5, 2006 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in number of muscle cramps experienced in a two week period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Reduction in number of muscle cramps experienced in a two week period. | ||||||||
| Change History | Complete list of historical versions of study NCT00372879 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Reduction in the duration of cramps and reduction in the severity of cramps | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS | ||||||||
| Official Title ICMJE | Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis. | ||||||||
| Brief Summary | Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis (ALS). This clinical trial will compare the response of high dose vitamin E supplementation to placebo for treatment of muscular cramps in patients with ALS. We hypothesize that vitamin E will be more effective than placebo in treating cramps. |
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| Detailed Description | This will be a single centre randomized placebo controlled crossover design trial. Participants will be randomized at study entry to protocol A (vitamin E first) or protocol B (placebo first). The first 2 weeks of the study will be a baseline assessment of the frequency, severity and duration of cramps. Patients will be blinded for the remainder of the duration of the study. For weeks 3-6 of the study, group A will receive vitamin E 800 IU bid and group B will receive placebo. For weeks 7-10 of the study, group A will receive placebo and group B will receive vitamin E. Participants will record cramp frequency and characteristics via a daily journal for the duration of the study, however the data analysis will focus on cramp frequency only during weeks 5-6 and 9-10. Weeks 3-4 and 7-8 will be used as time periods to allow the new drug to come to steady state and allow for washout of the previous drug. Data analysis will focus on the difference in cramp frequency in individual patients in each treatment period. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase III | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Amyotrophic Lateral Sclerosis | ||||||||
| Intervention ICMJE | Dietary Supplement: Vitamin E
Vitamin E 800IU bid |
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| Study Arms |
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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 | 32 | ||||||||
| Estimated Completion Date | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00372879 | ||||||||
| Other Study ID Numbers ICMJE | R-06-451, ALSClin-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. M. Strong, Lawson Health Research Institute | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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