Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00005674
• Date of registration: 26/05/2000
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]
• Date of first enrolment: May 2000
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00005674
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Creatine

Secondary ID(s)

M01RR00036

NCRR-M01RR00036-0745

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Muscular Dystrophy Association