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Home > "S" Clinical Trials Conditions > Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis  Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis
Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis
For Condition: Amyotrophic Lateral Sclerosis (ALS)
Status: Recruiting
Sponsor(s): The Avicena Group , National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: The purpose of this study is to determine whether nine months of administation of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis (ALS).
Details: Introduction: Twenty-one ALS patients were enrolled in a placebo controlled pilot study at the Carolinas Neuromuscular/ALS-MDA Center, The University of Texas Health Science Center at San Antonio and The University of New Mexico at Albuquerque. At all time points sampled over a nine month period, patients taking creatine monohydrate had either a significantly greater improvement in their strength or a more modest decline compared to the patients taking placebo. Overall analysis of variance is significant for both an effect of the drug (p=0.002) and time (p< 0.001).The pilot study also showed that quality of life, as measured by ALSFRS-R, correlated significantly with the observed changes in muscle strength (MVIC). Phase III Study: The primary objective of this study is to determine whether treatment with creatine monohydrate results in an increase in muscle strength relative to placebo in patients with amyotrophic lateral sclerosis (ALS), after three months, and at the end of a nine-month treatment period. The study is a Phase III, eight-center, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the safety and efficacy of creatine monohydrate in patients fulfilling the eligibility criteria. The subjects (n=156) will be randomized in a 1:1 ratio to receive treatment of highly purified creatine monohydrate or placebo (Dextrose, USP) for nine months. The subjects will be administered 10 grams of creatine monohydrate per day for the first five days, and then 5 grams per day thereafter. Each subject will be followed for the nine-month treatment period. The primary outcome measure for the study is change in upper extremity motor function after three weeks, and at the end of a nine-month treatment period as tested by MVIC. Strength in ten arm muscles will be measured (bilateral shoulder and elbow flexion/extension and grip). Patient safety will be assured by ongoing review of reports of adverse events, clinical laboratory data, and measurement of vital signs. These tests include: measurement of MVIC and muscle fatigue, measurement of FVC, completion of ALSFRS-R and SF-12 quality of life instruments, review of potential adverse effects, determination of vital signs and weight, serum creatinine and BUN, and urine dipstick for protein.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Expanded Access Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/80 Years
Genders: Both
Protocol Entry Criteria: - A clinical diagnosis of probable or definite lab-supported ALS, either SALS or FALS, according to modified El Escorial criteria. - Males or females, 21 to 80 years of age. - Patients receiving treatment with Rilutek® (riluzole) must be on a stable dose for at least 30 days immediately prior to enrollment. - Women of childbearing potential must be non-lactating and surgically sterile or using an effective method of birth control (double barrier or oral contraception) and have a negative pregnancy test. Women will be considered menopausal if they have not had a menstrual cycle (period) for two years. - Disease duration less than five years since symptom onset. - At least 5 of 10 testable upper extremity muscle groups of MRC grade 4 or better. - The patient must have given informed consent that has been approved by the appropriate Institutional Review Board (IRB).
Total Enrollment: 156
Location and Contact Information:
Duke University Medical Center *Not yet recruiting*
Durham, North Carolina, 27705
United States
Not yet recruiting Richard Bedlack
University of Texas Health Science Center *Recruiting*
San Antonio, Texas, 48284-7883
United States
Recruiting Carlayne Jackson 210-567-1945
University of New Mexico *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting John Chapin 505-272-6388
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28203-5812
United States
Recruiting Jeffrey Rosenfeld 704-446-6256
Rush-Presbyterian St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Matthew Meriggioli 312-563-2759
University of Kansas *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Arthur Dick 913-588-5095
University of California, San Francisco *Recruiting*
San Francisco, California, 94115
United States
Recruiting Deborah Gelinas 415-923-3957
University of Virginia Health System *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Lawrence Phillips 434-924-5361
Additional Information:
Study ID Numbers: AGI-ALS-III-01; Orphan Drug:01-1527
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069186
Other Amyotrophic Lateral Sclerosis (als) Studies:
1. Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis
Related Studies:
Other Amyotrophic Lateral Sclerosis (ALS) Clinical Trials
Other Maine Clinical Trials
Other Clinical Trials
Study of Creatine Monohydrate in Patients with Amyotrophic Lateral Sclerosis
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