Creatine for the Treatment of Amyotrophic Lateral Sclerosis

NCT ID: NCT00070993

Last Updated: 2006-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2006-05-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; Creatine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

creatine monohydrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of probable or definite ALS
• At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better
• At least 5 years from onset of symptoms

Exclusion Criteria

• Requires tracheostomy ventilation
• History of renal disease

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Office of Dietary Supplements (ODS)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Jeffrey Rosenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

California Pacific Medical Center

San Francisco, California, United States

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of New Mexico - Medical Center

Albuquerque, New Mexico, United States

University of Texas Health and Science Center

San Antonio, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

R01AT000967-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link