Clinical trial NCT00070993: Creatine for the Treatment of Amyotrophic Lateral Sclerosis
Official title: Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Creatine
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2003-10-13
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke's Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Albuquerque
country: United States
facility: University of New Mexico - Medical Center
state: New Mexico
city: San Antonio
country: United States
facility: University of Texas Health and Science Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Carolinas Medical Center
name: Jeffrey Rosenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: