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	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.

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Muscle Cramps Vitamin E

Drug Information available for: alpha-Tocopherol Tocopherol alpha-Tocopherol succinate Tocopherol acetate dl-alpha-Tocopherol

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]


Enrollment:	32
Study Start Date:	December 2006
Study Completion Date:	August 2010
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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

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

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


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
Study First Received:	September 5, 2006
Last Updated:	March 1, 2016
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 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

ClinicalTrials.gov processed this record on September 27, 2016