Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
NCT ID: NCT07040137
Last Updated: 2025-06-27
Study Results
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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RECRUITING
PHASE3
142 participants
INTERVENTIONAL
2025-07-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
KPS-0373
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.
Placebo
Oral administration
Interventions
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KPS-0373
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
18 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Research Site
Multiple Locations, , Japan
Countries
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Central Contacts
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Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd
Role: CONTACT
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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