Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
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ClinicalTrials.gov Identifier: NCT00372879 |
Recruitment Status
:
Completed
First Posted
: September 7, 2006
Last Update Posted
: March 3, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Dietary Supplement: Vitamin E | Phase 3 |
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
|
- Reduction in number of muscle cramps experienced in a two week period. [ Time Frame: 4 weeks ]
- Reduction in the duration of cramps and reduction in the severity of cramps [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00372879
Canada, Ontario | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 5A5 |
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 |
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 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:
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 |