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Home > "C" Clinical Trials Conditions > Creatine for the Treatment of Amyotrophic Lateral Sclerosis  Creatine for the Treatment of Amyotrophic Lateral Sclerosis
Creatine for the Treatment of Amyotrophic Lateral Sclerosis
For Condition: Amyotrophic Lateral Sclerosis
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , Office of Dietary Supplements (ODS)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 110
Location and Contact Information:
Overall Study Official:
JeffreyRosenfeld, Principal Investigator, Blumenthal Cancer Center at Carolinas Medical Center
California Pacific Medical Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Giovanna Kushner 415-600-3938
University of Texas Health and Science Center *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Freida Barefield 210-567-1979
University of New Mexico - Medical Center *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Martha Meister 505-272-3194
University of Virginia Health System *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Cindy Barnhill 434-243-2867
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Mary Martin 913-588-0645
Rush-Presbyterian St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Judith Richman 312-563-2759
Additional Information:
Study ID Numbers: R01 AT00967-01;
Study Start Date: December 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070993
Other Amyotrophic Lateral Sclerosis Studies:
1. Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
2. Determinants of Disease Severity in Amyotrophic Lateral Sclerosis
3. Clinical trial of creatine in amyotrophic lateral sclerosis [ALS]
4. Minocycline to Treat Amyotrophic Lateral Sclerosis
5. Safety testing of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Laughter & Crying)
Related Studies:
Other Amyotrophic Lateral Sclerosis Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Creatine for the Treatment of Amyotrophic Lateral Sclerosis
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