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

Study Description

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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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Michael Strong, Professor Department of Clinical Neurological Sciences, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00372879 History of Changes
Other Study ID Numbers:	R-06-451; ALSClin-001
First Posted:	September 7, 2006
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:

Amyotrophic Lateral Sclerosis; Sclerosis; Motor Neuron Disease; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases	Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents