Amyotrophic Lateral SclerosisPhase 3NCT00372879

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

A Phase 3 study testing Vitamin E in people with Amyotrophic Lateral Sclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis
What is being tested?: Vitamin E
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: Dec 2006to Aug 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

London Health Sciences Centre
London, Ontario, N6A 5A5

Other trials in Canada

About this study

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

Read the 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.

Conditions: Amyotrophic Lateral Sclerosis
Being tested: Vitamin E
Keywords: amyotrophic lateral sclerosis, vitamin E, muscle cramp
Medical subject headings: Amyotrophic Lateral Sclerosis, Muscle Cramp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin EDietary supplement
Vitamin E 800IU bid

Study groups in NCT00372879
Study group	Role	What they receive
Crossover group 1	Experimental	Vitamin E first and placebo second Receives: Dietary Supplement: Vitamin E
Crossover group 2	Experimental	Placebo first then vitamin E Receives: Dietary Supplement: Vitamin E

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in number of muscle cramps experienced in a two week period.
Measured: 4 weeks

Secondary outcomes (1)

Reduction in the duration of cramps and reduction in the severity of cramps
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Aug 2010

First posted7 Sep 2006 (estimated)
Study startDec 2006
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00372879
Sponsor's protocol ID: R-06-451
Other IDs: ALSClin-001
Status last verified: Mar 2016
First submitted: 5 Sep 2006
Last updated: 3 Mar 2016
Results posted: No
Data monitoring committee: No

Publications

Steele DW, Adam GP, Saldanha IJ, Kanaan G, Zahradnik ML, Danilack-Fekete VA, Stuebe AM, Peahl AF, Chen KK, Balk EM. Postpartum Home Blood Pressure Monitoring: A Systematic Review. Obstet Gynecol. 2023 Aug 1;142(2):285-295. doi: 10.1097/AOG.0000000000005270. Epub 2023 Jun 13.
PubMed 37311173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)

All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis.
ClinicalTrials.gov ID: NCT00372879
Acronym / sponsor ID: R-06-451
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis, vitamin E, muscle cramp
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Study start: Dec 2006
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 7 Sep 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Crossover group 1	Experimental	Dietary Supplement: Vitamin EVitamin E first and placebo second
Crossover group 2	Experimental	Dietary Supplement: Vitamin EPlacebo first then vitamin E

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin EVitamin E 800IU bid	Dietary supplement	Crossover group 1, Crossover group 2

Primary outcome

Reduction in number of muscle cramps experienced in a two week period.
Time frame: 4 weeks

1 secondary outcome

Reduction in the duration of cramps and reduction in the severity of cramps
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
Derived from this study: PubMed 37311173Steele DW, Adam GP, Saldanha IJ, Kanaan G, Zahradnik ML, Danilack-Fekete VA, Stuebe AM, Peahl AF, Chen KK, Balk EM. Postpartum Home Blood Pressure Monitoring: A Systematic Review. Obstet Gynecol. 2023 Aug 1;142(2):285-295. doi: 10.1097/AOG.0000000000005270. Epub 2023 Jun 13.

Related trials for Amyotrophic Lateral Sclerosis

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Strong, MD, FRCPC principal investigator

Clinical Neurological Sciences, London Health Sciences Centre

Christen L Shoesmith, MD, FRCPC study director

Clinical Neurological Sciences, London Health Sciences Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in number of muscle cramps experienced in a two week period. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00372879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.