A Phase IIa Study of TAS-205 for Duchenne Muscular Dystrophy

NCT02752048 ↗

Phase 2 Completed 36 enrolled Taiho Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.

Timeline

Start: 2016-05
Primary completion: 2017-05-15
Completion: 2017-10-17

Outcome

Missed primary endpoint

paper The mean (95% confidence interval) difference from the placebo group was 13.5 (-43.3 to 70.2) m in the TAS-205 low-dose group PMID 31957953 ↗

Publications

Komaki H, Maegaki Y, Matsumura T, Shiraishi K, Awano H, Nakamura A, Kinoshita S, Ogata K, Ishigaki K, Saitoh S, Funato M, Kuru S, Nakayama T, Iwata Y, Yajima H, Takeda S. Early phase 2 trial of TAS-205 in patients with Duchenne muscular dystrophy. Ann Clin Transl Neurol. 2020 Feb;7(2):181-190. doi: 10.1002/acn3.50978. Epub 2020 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TAS-205	Unknown	6.67 mg/kg	Oral
Subject	TAS-205	Unknown	13.33 mg/kg	Oral
Subject	TAS-205	Unknown	26.67 mg/kg	Oral