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Home > "C" Clinical Trials Conditions > Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis  Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
For Condition: Amyotrophic Lateral Sclerosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: The objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been hypothesized that in ALS there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death. Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of ALS and Huntington's disease. This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States, including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well tolerated, a phase 3 study with survival as the primary outcome measure will be initiated. 114 eligible subjects will be randomized to receive treatment for 6 months of (1) active creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6 months. The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and elbow flexion and extension). Secondary outcome measures include grip strength, motor unit number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in urine), and the safety and tolerability of creatine.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - ALS - FVC >=50% - Abnormality in upper and/or lower extremity motor function - Not pregnant - Disease duration <5 years
Total Enrollment:
Location and Contact Information:
University of Vermont
Burlington, Vermont, 05401
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00109-0750; M01RR00109
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005766
Other Amyotrophic Lateral Sclerosis Studies:
1. A 12-week, multicenter, safety and dose-ranging study of 3 oral doses of TCH346 in patients with Amyotrophic Lateral Sclerosis
2. Nuclear Magnetic Spectroscopy Imaging to Evaluate Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis
3. Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)
4. Is there a higher than expected occurrence of ALS among deployed veterans as compared to non-deployed Gulf War veterans?
5. Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease
Related Studies:
Other Amyotrophic Lateral Sclerosis Clinical Trials
Other Vermont Clinical Trials
Other Burlington Clinical Trials
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
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