An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Kissei

Status and phase: Completed; Phase 3

Conditions: Spinocerebellar Degeneration

Treatments: Drug: Placebo; Drug: KPS-0373

Study type: Interventional

Funder types: Industry

Identifiers

NCT02889302

KPS1305

Details and patient eligibility

About

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

Enrollment: 203 patients

Sex: All

Ages: 20+ 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: Double Blind

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203 participants in 2 patient groups, including a placebo group

KPS-0373

Experimental group

Treatment:

Drug: KPS-0373

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo