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Cited by 293

The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.

A clinical trial of creatine in ALS

Shefner, J. M., Cudkowicz, M. E., Schoenfeld, D., Conrad, T., Taft, J., Chilton, M., Urbinelli, L., Qureshi, M., Zhang, H., Pestronk, A., Caress, J., Donofrio, P., Sorenson, E., Bradley, W., Lomen-Hoerth, C., Pioro, E., Rezania, K., Ross, M., Pascuzzi, R., Heiman-Patterson, T., Tandan, R., Mitsumoto, H., Rothstein, J., Smith-Palmer, T., MacDonald, D., Burke, D., the NEALS Consortium·2004·Neurology
DOI 10.1212/01.wnl.0000142992.81995.f0
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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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Authors
Shefner, J. M., Cudkowicz, M. E., Schoenfeld, D., Conrad, T., Taft, J., Chilton, M., Urbinelli, L., Qureshi, M., Zhang, H., Pestronk, A., Caress, J., Donofrio, P., Sorenson, E., Bradley, W., Lomen-Hoerth, C., Pioro, E., Rezania, K., Ross, M., Pascuzzi, R., Heiman-Patterson, T., Tandan, R., Mitsumoto, H., Rothstein, J., Smith-Palmer, T., MacDonald, D., Burke, D., & the NEALS Consortium
Venue
Neurology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2004-11-09
Volume
63
Issue
9
Pages
1656-1661
ISSN
  • 0028-3878 (ISSN-L)
  • 1526-632X
DOI
10.1212/01.wnl.0000142992.81995.f0
OpenAlex
W2067856511
Cited by
293
References
2
FWCI
12.24
Type
journal article
Language
en
Open access
closed

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