## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** R-06-451
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
#### Secondary ID Infos
**ID:** ALSClin-001
### Status Module
#### Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-03-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-03-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Start Date
**Date:** 2006-12

**Status Verified Date:** 2016-03

#### Study First Post Date
**Date:** 2006-09-07
**Type:** ESTIMATED
**Study First Submit Date:** 2006-09-05
**Study First Submit QC Date:** 2006-09-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lawson Health Research Institute

#### Responsible Party

**Investigator Affiliation:** Lawson Health Research Institute

**Investigator Full Name:** Michael Strong

**Investigator Title:** Professor Department of Clinical Neurological Sciences

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Amyotrophic Lateral Sclerosis

**Keywords:**

- amyotrophic lateral sclerosis

- vitamin E

- muscle cramp

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Vitamin E first and placebo second

**Intervention Names:**

- Dietary Supplement: Vitamin E

**Label:** Crossover group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo first then vitamin E

**Intervention Names:**

- Dietary Supplement: Vitamin E

**Label:** Crossover group 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Crossover group 1

- Crossover group 2

**Description:** Vitamin E 800IU bid

**Name:** Vitamin E

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Measure:** Reduction in the duration of cramps and reduction in the severity of cramps

**Time Frame:** 4 weeks

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** Canada

**Facility:** London Health Sciences Centre

**State:** Ontario

**Zip:** N6A 5A5

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Neurological Sciences, London Health Sciences Centre

**Name:** Michael J Strong, MD, FRCPC

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Clinical Neurological Sciences, London Health Sciences Centre

**Name:** Christen L Shoesmith, MD, FRCPC

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000057177

- Term: TDP-43 Proteinopathies

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: HIGH

- As Found: Lateral Sclerosis

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: M15837

- Name: Spasm

- Relevance: LOW

- As Found: Unknown

- ID: M12077

- Name: Muscle Cramp

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28759

- Name: TDP-43 Proteinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: T4699

- Name: Primary Lateral Sclerosis

- Relevance: HIGH

- As Found: Lateral Sclerosis

### Condition Browse Module - Meshes

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000000690

- Term: Amyotrophic Lateral Sclerosis

- ID: D000012598

- Term: Sclerosis

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M22972

- Name: Tocopherols

- Relevance: LOW

- As Found: Unknown

- ID: M17553

- Name: Vitamin E

- Relevance: HIGH

- As Found: Untreated

- ID: M22975

- Name: Tocotrienols

- Relevance: LOW

- As Found: Unknown

- ID: M22969

- Name: alpha-Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T466

- Name: Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: T467

- Name: Tocotrienol

- Relevance: LOW

- As Found: Unknown

- ID: T480

- Name: Vitamin E

- Relevance: HIGH

- As Found: Untreated

### Intervention Browse Module - Meshes

- ID: D000014810

- Term: Vitamin E

### Misc Info Module

- Version Holder: 2024-05-24
