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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Muscular Dystrophy Association |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00005674 |
The purpose of this study is to evaluate the safety and effectiveness of creatine treatment in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS but the cause of the cell death is unknown. It has been shown that there is overactive nerve activity due to increased levels of a chemical called glutamate and that there is abnormal cellular metabolism along with increased production of substance called "free radicals." Improving cellular metabolism and readjusting the activity of glutamate in the brain may be beneficial to ALS patients.
Creatine is a naturally occurring compound, which improves energy metabolism in cells. Creatine has been given to patients with energy metabolism defects in their muscles, and to athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS have received creatine for up to six months without any side effects. Overall, creatine has been well tolerated and safe.
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: Creatine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Half of the subjects in this study will be selected by chance to receive creatine treatment for 6 months and the other half to receive placebo. Neither the subject nor the investigator will know which drug the subject is receiving, although this information will be available in case of emergency. It is anticipated that all subjects will have the choice to receive creatine after the 6 months study in an open-label study for an additional 12 months. A total of 114 patients will participate at 15 centers. Approximately 8 subjects will be enrolled at the Washington University.
The effectiveness of creatine will be determined first by assessing any changes in strength in the arms and second by changes in grip strength, functional activities, electromyography changes or changes of the level of SOH 2'dG in the urine.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | NCRR-M01RR00036-0745, M01RR00036 |
Study First Received: | May 26, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005674 History of Changes |
Health Authority: | United States: Federal Government |
Lou Gehrig's Disease Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Sclerosis Neurodegenerative Diseases Degenerative Motor System Disease Motor Neuron Disease |
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |