Funded in part by Daiichi Sankyo Foundation of Life Science, Daiichi Sankyo Europe
Treatment with Creatine Monohydrate in Spinal and Bulbar Muscular Atrophy: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial
Hijikata Y, Katsuno M, Suzuki K, Hashizume A, Araki A, Yamada S, Inagaki T, Ito D, Hirakawa A, Kinoshita F, Gosho M, Sobue G
JMIR research protocols · 8 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Daiichi Sankyo Foundation of Life Science
- Government
- Japan Society for the Promotion of Science
- Government
- Japan Science and Technology Agency
- Unclassified
- Core Research for Evolutional Science and Technology
- Company
- Daiichi Sankyo Europe
- Grants
- Japan Society for the Promotion of Science (26670440); Japan Society for the Promotion of Science (26670439); Japan Society for the Promotion of Science (26293206)
Based on 5 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2018-03-05 · JMIR Res Protoc · vol. 7 · issue 3 · p. e69
- Publisher
- JMIR Publications
- Cited
- 13 citations · more than 80% of similar papers · 1.4× the field average
- References
- 52 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Amyotrophic Lateral Sclerosis Research · Parkinson's Disease and Spinal Disorders · Neurogenetic and Muscular Disorders Research
- Keywords
- Spinal and bulbar muscular atrophy, Medicine, Spinal muscular atrophy, Atrophy, Motor neuron, Placebo, Creatine, Physical therapy, Physical medicine and rehabilitation, Disease, Weakness, Skeletal muscle, Neuromuscular disease, Internal medicine, Pathology, Anatomy, Alternative medicine, Prostate cancer
12 authors
From JP
- Yasuhiro HijikataNagoya University
- Masahisa KatsunoNagoya University
- Keisuke SuzukiNational Center for Geriatrics and Gerontology; Nagoya University
- Atsushi HashizumeNagoya University
- Amane ArakiNagoya University
- Shinichiro YamadaNagoya University
Abstract
Background
Although spinal and bulbar muscular atrophy (SBMA) has been classified as a motor neuron disease, several reports have indicated the primary involvement of skeletal muscle in the pathogenesis of this devastating disease. Recent studies reported decreased intramuscular creatine levels in skeletal muscles in both patients with SBMA and transgenic mouse models of SBMA, which appears to contribute to muscle weakness.
Objective
The present study aimed to examine the efficacy and safety of oral creatine supplementation to improve motor function in patients with SBMA.
Methods
A randomized, double-blind, placebo-controlled, three-armed clinical trial was conducted to assess the safety and efficacy of creatine therapy in patients with SBMA. Patients with SBMA eligible for this study were assigned randomly in a 1:1:1 ratio to each group of placebo, 10 g, or 15 g daily dose of creatine monohydrate in a double-blind fashion. Participants took creatine or placebo orally 3 times a day for 8 weeks. Outcome measurements were results of neurological assessments, examinations, and questionnaires collected at baseline and at weeks 4, 8, and 16 after a washout period. The primary endpoint was the change in handgrip strength values from baseline to week 8. The secondary endpoints included the following: results of maximum voluntary isometric contraction tests of extremities; tongue pressure; results of the 15-foot timed walk test and the rise from bed test; modified quantitative myasthenia gravis score; respiratory function test results; activities of daily living assessed with the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale and the Spinal and Bulbar Muscular Atrophy Functional Rating Scale; skeletal muscle mass measured with dual-energy X-ray absorptiometry; urinary 8-hydroxydeoxyguanosine levels; and questionnaires examining the quality of life, swallowing function, and fatigue.
Results
Participant enrollment in the trial started from June 2014 and follow-up was completed in July 2015. The study is currently being analyzed.
Conclusions
This is the first clinical trial evaluating creatine therapy in SBMA. Given that creatine serves as an energy source in skeletal muscles, recovery of intramuscular creatine concentration is expected to improve muscle strength.
Trial registration
University Hospital Medical Information Network Clinical Trials Registry UMIN000012503; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014611 (Archived by WebCite at http://www.webcitation.org/6xOlbPkg3).
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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