Spinocerebellar Ataxia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Japanese SCD patients with mild to moderate ataxia

Locations
Other Locations
Japan
Research Site
RECRUITING
Multiple Locations
Contact Information
Primary
Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd
rinsyousiken@pharm.kissei.co.jp
Email only
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 142
Treatments
Experimental: KPS-0373 group
* Screening period: One placebo tablet is orally administrated once daily after breakfast for 4 weeks.~* Treatment period: One KPS-0373 2.4 mg tablet is orally administered once daily after breakfast in 24 weeks.
Placebo_comparator: Placebo group
* Screening period: One placebo tablet is orally administrated once daily after breakfast for 4 weeks.~* Treatment period: One placebo tablet is orally administered once daily after breakfast in 24 weeks.
Related Therapeutic Areas
Spinocerebellar Ataxia
Sponsors
Leads: Kissei Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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