MedPath

Creatine for the Treatment of Amyotrophic Lateral Sclerosis

Phase 2
Completed
Conditions
Amyotrophic Lateral Sclerosis
Registration Number
NCT00070993
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Brief Summary

Creatine is a naturally occurring chemical involved in the production of energy in muscle. Abnormalities in creatine have been linked to the progression of degenerative neuromuscular diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study will test whether taking creatine can improve the symptoms of ALS.

Detailed Description

Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder selectively affecting motor neurons, resulting in progressive weakness. Currently there is no known cure and a specific cause has not been identified. Creatine is a nutritional supplement that improves mitochondrial function and has been shown to protect motor neurons in animal models of ALS. Preliminary research indicates that creatine may also improve strength in patients with ALS. This study will determine the effect of creatine treatment on short-term muscle strength and long-term muscle deterioration in patients with ALS.

Participants in this study will be randomly assigned to receive either creatine or placebo. Participants will be enrolled in the study for 9 months. Quantitative muscle testing will be done weekly for the first 3 weeks; participants will then be followed monthly for the next 4 months and bimonthly for the remainder of the 9-month study. The study will also monitor purposeful exercise to determine if this enhances the benefit of creatine usage on muscle strength. Pulmonary function testing will accompany the muscle testing to determine if creatine strengthens respiratory muscles, thereby enhancing pulmonary function.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
110
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

Rush-Presbyterian St. Luke's Medical Center

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Chicago, Illinois, United States

University of New Mexico - Medical Center

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Albuquerque, New Mexico, United States

University of Texas Health and Science Center

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San Antonio, Texas, United States

California Pacific Medical Center

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San Francisco, California, United States

University of Virginia Health System

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Charlottesville, Virginia, United States

University of Kansas Medical Center

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Kansas City, Kansas, United States

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