Status:
COMPLETED
Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 treat...
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 fir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00372879
Start Date
December 1 2006
End Date
August 1 2010
Last Update
March 3 2016
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5