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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00372879
First received: September 5, 2006
Last updated: January 20, 2009
Last verified: January 2009
  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:


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 ]

Estimated Enrollment: 32
Study Start Date: December 2006
Estimated Study Completion Date: August 2010
Estimated 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
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

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

No publications provided

Responsible Party: Dr. M. Strong, 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: January 20, 2009
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
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014