A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Summary

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Timeline

Start

2013-10-09

Primary completion

2015-01

Completion

2015-01

Outcome

Missed primary endpoint

paper The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies. PMID 31937586 ↗

release “2013年～2015年に第Ⅲ相臨床試験を実施し、この成績に基づき、2016年～2018年に追加の第Ⅲ相臨床試験を実施いたしましたが、いずれの試験においても、主要評価項目である運動失調を評価するためのSARA合計スコアの変化量は、プラセボ群と比べて統計学的に有意な改善を認めませんでした” kissei.co.jp ↗

Publications

• Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rovatirelin	Small molecule	1.6 mg	—
Subject	rovatirelin	Small molecule	2.4 mg	—

Indications