Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

• Status: Unknown status
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether nine months of administration of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis (ALS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Avicena Group

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).