Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Muscular Dystrophy Association

Criteria

Inclusion Criteria:

• A clinical diagnosis of definite, probably or laboratory supported probably ALS, either sporadic or familial ALS according to a modified El Escorial criteria

• Willing and able to give informed consent

• FVC greater than or equal to 50% predicted

• Evidence of abnormality in upper and/or lower extremity motor function (clinical evidence of muscle atrophy and weakness in an upper and/or lower extremity). The patient should have at least 4 or 8 testable upper extremity muscle groups.

• Subjects may take riluzole. Riluzole must have been at stable doses for at least thirty days prior to baseline visit.

• If woman of childbearing age, must be non-lactating and surgically sterile or using an effective method of birth control (double barrier or oral contraceptive) and have a negative pregnancy test

• Disease duration less than five years