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Completed

NCT Number: NCT00070993

Creatine for the Treatment of Amyotrophic Lateral Sclerosis

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Pacific Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine monohydrate

Drug

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

  • Office of Dietary Supplements (ODS)

Registry information

Official study title

Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis

Important dates

Study start
2002
Study completion
2006
First posted
Oct 13, 2003
Registry last updated
Aug 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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