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

NCT ID: NCT07040137

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinocerebellar Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

KPS-0373

Intervention Type DRUG

Oral administration

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration

Interventions

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KPS-0373

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Multiple Locations, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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

Role: CONTACT

Email only

Other Identifiers

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jRCT

Identifier Type: REGISTRY

Identifier Source: secondary_id

KPS1306

Identifier Type: -

Identifier Source: org_study_id

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