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Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Lawson Health Research Institute.   Recruitment status was  Recruiting
Study NCT00372879   Information provided by Lawson Health Research Institute

First Received on September 5, 2006.   Last Updated on January 20, 2009   History of Changes

September 5, 2006
January 20, 2009
December 2006
August 2010   (final data collection date for primary outcome measure)
Reduction in number of muscle cramps experienced in a two week period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction in number of muscle cramps experienced in a two week period.
Complete list of historical versions of study NCT00372879 on ClinicalTrials.gov Archive Site
Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction in the duration of cramps and reduction in the severity of cramps
 
Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis.

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.

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.

Interventional
Phase III
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Dietary Supplement: Vitamin E
Vitamin E 800IU bid
  • Experimental: Crossover group 1
    Vitamin E first and placebo second
    Intervention: Dietary Supplement: Vitamin E
  • Experimental: Crossover group 2
    Placebo first then vitamin E
    Intervention: Dietary Supplement: Vitamin E
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (> age 18 years)
  • Probable or definite ALS by El Escorial Revised criteria
  • At least 2 painful muscle cramps in one or more of the limbs per week.
  • May have tried other medications for cramping in the past.
  • If participants are currently on treatment for cramps and are continuing to have at least 2 cramps per week, they can be included in the trial. In this situation, the individual's previous cramp medication can be continued during the trial.
  • Ideally, patients should not have any medication alterations during the duration of the trial.
  • Willing to discontinue supplementary vitamin E and multivitamins containing > 400 IU of vitamin E during the trial.

Exclusion Criteria:

  • Patients who are unable to safely consume the trial capsules. Individuals with significant dysphagia can be included into the study if they have a functioning PEG tube or GJ tube, through which the medication can be given.
  • Patients who are unable to fill out the daily diary, either personally or via a proxy.
  • Patients who have had medication changes within the last 4 weeks prior to the onset of the trial will be excluded.
Both
18 Years and older
No
Contact: Ann Rowe, RN 519-663-3934 annm.rowe@lhsc.on.ca
Canada
 
NCT00372879
R-06-451, ALSClin-001
No
Dr. M. Strong, Lawson Health Research Institute
Lawson Health Research Institute
 
Principal Investigator: Michael J Strong, MD, FRCPC Clinical Neurological Sciences, London Health Sciences Centre
Study Director: Christen L Shoesmith, MD, FRCPC Clinical Neurological Sciences, London Health Sciences Centre
Lawson Health Research Institute
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP