World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00070993
Date of registration: 09/10/2003
Prospective Registration: No
Primary sponsor: National Center for Complementary and Integrative Health (NCCIH)
Public title: Creatine for the Treatment of Amyotrophic Lateral Sclerosis
Scientific title: Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Date of first enrolment: December 2002
Target sample size: 110
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00070993
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Jeffrey Rosenfeld, MD
Address: 
Telephone:
Email:
Affiliation:  Carolinas Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria

- Diagnosis of probable or definite ALS

- At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow
extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better

- At least 5 years from onset of symptoms

Exclusion Criteria

- Requires tracheostomy ventilation

- History of renal disease



Age minimum: 21 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Intervention(s)
Drug: creatine monohydrate
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
R01 AT000967-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Office of Dietary Supplements (ODS)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history