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NCT02752048
A Randomized Phase IIa Study of TAS-205 in Patients With Duchenne Muscular Dystrophy
Phase 2 trial testing TAS-205 in Duchenne Muscular Dystrophy in 36 participants. Completed in 17 October 2017.
15 May 2017
Quick facts
| Lead sponsor | Taiho Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 May 2016 |
| Primary completion | 15 May 2017 |
| Estimated completion | 17 October 2017 |
| Sites | 11 locations across Japan |
Drugs / interventions tested
- TAS-205 — full drug profile →
- Placebo
Conditions studied
- Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →
Sponsor
Taiho Pharmaceutical Co., Ltd. — full company profile →
Who can join
5 and older, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Change From Baseline to 24 Weeks in the 6-minute Walk Distance (6MWD)
Time frame: baseline, 24 weeks
The distance the subject can walk as fast as possible in 6 minutes will be evaluated.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Muscle and cardiac therapeutic strategies for Duchenne muscular dystrophy: past, present, and future.
Łoboda A, Dulak J. · · 2020 · cited 57× · PMID 32691346 · DOI 10.1007/s43440-020-00134-x -
Early phase 2 trial of TAS-205 in patients with Duchenne muscular dystrophy.
Komaki H, Maegaki Y, Matsumura T, Shiraishi K, et al · · 2020 · cited 22× · PMID 31957953 · DOI 10.1002/acn3.50978 -
A phase I study of TAS-205 in patients with Duchenne muscular dystrophy.
Takeshita E, Komaki H, Shimizu-Motohashi Y, Ishiyama A, et al · · 2018 · cited 20× · PMID 30480028 · DOI 10.1002/acn3.651 -
Targeted genetic therapies for inherited disorders that affect both cardiac and skeletal muscle.
Psaras Y, Toepfer CN. · · 2024 · cited 3× · PMID 38095849 · DOI 10.1113/ep090436 -
Urinary prostaglandin D<sub>2</sub> and E<sub>2</sub> metabolites are elevated with disease severity in patients with Fukuyama congenital muscular dystrophy.
Ishigaki K, Takeuchi A, Taniguchi-Ikeda M, Sato T, et al · · 2025 · cited 1× · PMID 40011677 · DOI 10.1038/s41598-025-91539-2
Verify or expand the search:
- PubMed search for NCT02752048
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Duchenne Muscular Dystrophy
Currently open trials in the same condition.
- NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
- NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
- NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
- NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
- NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting
Other Taiho Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05691660 — A Study of TAS3731 in Healthy Adults · Phase 1 · completed
- NCT05621447 — A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects · Phase 1 · completed
- NCT05335499 — A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria · Phase 2 · completed
- NCT04825431 — Mass Balance Study of [14C] TAS-205 in Healthy Volunteers · Phase 1 · completed
- NCT04512053 — A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02752048 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taiho Pharmaceutical Co., Ltd.
- Last refreshed: 8 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02752048.
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