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Creatine for the Treatment of Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070993
Recruitment Status : Completed
First Posted : October 13, 2003
Last Update Posted : August 4, 2006
Office of Dietary Supplements (ODS)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: creatine monohydrate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Study Start Date : December 2002
Study Completion Date : May 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070993

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United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Illinois
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New Mexico
University of New Mexico - Medical Center
Albuquerque, New Mexico, United States, 87131
United States, Texas
University of Texas Health and Science Center
San Antonio, Texas, United States, 78284
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
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Principal Investigator: Jeffrey Rosenfeld, MD Carolinas Medical Center
Layout table for additonal information Identifier: NCT00070993    
Other Study ID Numbers: R01AT000967-01 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2003    Key Record Dates
Last Update Posted: August 4, 2006
Last Verified: August 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases