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

Kissei

Status and phase: Enrolling; Phase 3

Conditions: Spinocerebellar Degeneration

Treatments: Drug: KPS-0373; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07040137

jRCT (Registry Identifier)

KPS1306

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 2 patient groups, including a placebo group

KPS-0373 group

Experimental group

Description:

* 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.

Treatment:

Drug: KPS-0373

Placebo group

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Placebo