Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS - Full Text View

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	Drug: Vitamin E	Phase III

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis Muscle Cramps

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis.

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Reduction in number of muscle cramps experienced in a two week period.

Secondary Outcome Measures:

Reduction in the duration of cramps and reduction in the severity of cramps

Estimated Enrollment:	32
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372879

Contacts


Contact: Ann Rowe, RN	519-663-3934	annm.rowe@lhsc.on.ca

Locations


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

Sponsors and Collaborators

Lawson Health Research Institute

Investigators


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

Study ID Numbers:	R-06-451, ALSClin-001
First Received:	September 5, 2006
Last Updated:	January 5, 2007
ClinicalTrials.gov Identifier:	NCT00372879
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

amyotrophic lateral sclerosis

vitamin E

muscle cramp

Study placed in the following topic categories:

Tocopherol acetate

Spinal Cord Diseases

Central Nervous System Diseases

Sclerosis

Degenerative motor system disease

Muscle Cramp

Neurodegenerative Diseases

Motor neuron disease

Alpha-Tocopherol

Tocopherols

Vitamin E

Amyotrophic lateral sclerosis

Neuromuscular Diseases

Amyotrophic Lateral Sclerosis

Lou Gehrig's disease

Motor Neuron Disease

Additional relevant MeSH terms:

Antioxidants

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Growth Substances

Vitamins

Physiological Effects of Drugs

Nervous System Diseases

Micronutrients

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00372879