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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Vitamin E

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, vitamin E, muscle cramp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Crossover group 1

Crossover group 2

Arm Description

Vitamin E first and placebo second

Placebo first then vitamin E

Outcomes

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

Full Information

NCT ID

NCT00372879

First Posted

September 5, 2006

Last Updated

March 1, 2016

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00372879

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis, vitamin E, muscle cramp

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crossover group 1

Arm Type

Experimental

Arm Description

Vitamin E first and placebo second

Arm Title

Crossover group 2

Arm Type

Experimental

Arm Description

Placebo first then vitamin E

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin E

Intervention Description

Vitamin E 800IU bid

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Strong, MD, FRCPC

Organizational Affiliation

Clinical Neurological Sciences, London Health Sciences Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christen L Shoesmith, MD, FRCPC

Organizational Affiliation

Clinical Neurological Sciences, London Health Sciences Centre

Official's Role

Study Director

Facility Information:

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

12. IPD Sharing Statement

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

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