NCT00372879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

3.7 years

First QC Date

September 5, 2006

Last Update Submit

March 1, 2016

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosisvitamin Emuscle cramp

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (1)

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

    4 weeks

Study Arms (2)

Crossover group 1

EXPERIMENTAL

Vitamin E first and placebo second

Dietary Supplement: Vitamin E

Crossover group 2

EXPERIMENTAL

Placebo first then vitamin E

Dietary Supplement: Vitamin E

Interventions

Vitamin EDIETARY_SUPPLEMENT

Vitamin E 800IU bid

Crossover group 1Crossover group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37311173DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisMuscle Cramp

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michael J Strong, MD, FRCPC

    Clinical Neurological Sciences, London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Christen L Shoesmith, MD, FRCPC

    Clinical Neurological Sciences, London Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Department of Clinical Neurological Sciences

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

CA(1)