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Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372879
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
Michael Strong, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: Vitamin E Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction in number of muscle cramps experienced in a two week period. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372879

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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
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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

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Responsible Party: Michael Strong, Professor Department of Clinical Neurological Sciences, Lawson Health Research Institute Identifier: NCT00372879    
Other Study ID Numbers: R-06-451
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by Michael Strong, Lawson Health Research Institute:
amyotrophic lateral sclerosis
vitamin E
muscle cramp
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents