Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Dietary Supplement: Vitamin E |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis. |
- Reduction in number of muscle cramps experienced in a two week period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Crossover group 1
Vitamin E first and placebo second
|
Dietary Supplement: Vitamin E
Vitamin E 800IU bid
|
|
Experimental: Crossover group 2
Placebo first then vitamin E
|
Dietary Supplement: Vitamin E
Vitamin E 800IU bid
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Ann Rowe, RN | 519-663-3934 | annm.rowe@lhsc.on.ca |
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Contact: Ann Rowe, RN 1-519-663-3934 annm.rowe@lhsc.on.ca | |
| Principal Investigator: Michael J Strong, MD, FRCPC | |
| Sub-Investigator: Christen L Shoesmith, MD, FRCPC | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. M. Strong, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00372879 History of Changes |
| Other Study ID Numbers: | R-06-451, ALSClin-001 |
| Study First Received: | September 5, 2006 |
| Last Updated: | January 20, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
amyotrophic lateral sclerosis vitamin E muscle cramp |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
Vitamin E Alpha-Tocopherol Tocopherols Tocotrienols Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013