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Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration

Recruiting Phase 3 Interventional Study
Spinocerebellar Degeneration
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
142 (estimated)
Sponsor
Kissei Pharmaceutical Co., Ltd. · Industry
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About This Trial

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study to evaluate the efficacy and safety of KPS-0373 given once daily after breakfast in 142 patients with spinocerebellar degeneration . This study consists of the 4-week screening period, 24-week treatment period, and 4-week follow-up period.

Trial Locations

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Eligibility Criteria
Inclusion Criteria: * Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: * Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Contacts

Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd

Email only

rinsyousiken@pharm.kissei.co.jp

CONTACT

NCT ID: NCT07040137 Source: ClinicalTrials.gov