Journal article
A clinical trial of creatine in ALS
Neurology, v 63(9), pp 1656-1661
09 Nov 2004
PMID: 15534251
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background: Mitochondrial dysfunction occurs early in the course of ALS, and the mitochondria may be an important site for therapeutic intervention. Creatine stabilizes the mitochondrial transition pore, and is important in mitochondrial ATP production. In a transgenic mouse model of ALS, administration of creatine prolongs survival and preserves motor function and motor neurons.
Methods: The authors conducted a randomized double-blind, placebo controlled trial on 104 patients with ALS from 14 sites to evaluate the efficacy of creatine supplementation in ALS. The primary outcome measure was maximum voluntary isometric contraction of eight upper extremity muscles, with secondary outcomes including grip strength, ALS Functional Rating Scale–Revised, and motor unit number estimates. Patients were treated for 6 months, and evaluated monthly.
Results: Creatine was tolerated well, but no benefit of creatine could be demonstrated in any outcome measure. CI analysis showed that the study, although powered to detect a 50% or greater change in rate of decline of muscle strength, actually made an effect size of greater than 23% unlikely. It was also demonstrated that motor unit number estimation was performed with acceptable reproducibility and tolerability, and may be a useful outcome measure in future clinical trials.
Conclusion: Any beneficial effect of creatine at 5 g per day in ALS must be small. Other agents should be considered in future studies of therapeutic agents to address mitochondrial dysfunction in ALS. In addition, motor unit number estimation may be a useful outcome measure for future clinical trials in ALS.
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Details
- Title
- A clinical trial of creatine in ALS
- Creators
- NEALS Consortium (Collaboration)J. M Shefner (Corresponding Author) - SUNY Upstate Medical UniversityM. E Cudkowicz - Massachusetts General HospitalJ Caress - Wake Forest UniversityP Donofrio - Wake Forest UniversityE Sorenson - Mayo ClinicW Bradley - University of MiamiC Lomen-Hoerth - University of California, San FranciscoE Pioro - Cleveland ClinicK Rezania - University of ChicagoM Ross - University of KentuckyR Pascuzzi - University of IndianapolisT Heiman-Patterson - Hahnemann University HospitalD Schoenfeld - Massachusetts General HospitalR Tandan - University of VermontH Mitsumoto - Columbia UniversityJ Rothstein - Johns Hopkins UniversityT Smith-Palmer - St. Francis Xavier UniversityD Macdonald - St. Francis Xavier UniversityD Burke - St. Francis Xavier UniversityT Conrad - SUNY Upstate Medical UniversityJ Taft - SUNY Upstate Medical UniversityM Chilton - SUNY Upstate Medical UniversityL Urbinelli - Massachusetts General HospitalM Qureshi - Massachusetts General HospitalH Zhang - Massachusetts General HospitalA Pestronk - Washington University in St. Louis
- Publication Details
- Neurology, v 63(9), pp 1656-1661
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Health Management and Policy
- Web of Science ID
- WOS:000224987700021
- Scopus ID
- 2-s2.0-8644289377
- Other Identifier
- 991019168339904721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Clinical Neurology