A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Kissei

Status and phase: Completed; Phase 2

Conditions: SCD

Treatments: Drug: Placebo; Drug: KPS-0373

Study type: Interventional

Funder types: Industry

Identifiers

NCT01384435

KPS1203

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Enrollment: 200 estimated 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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200 participants in 5 patient groups, including a placebo group

KPS-0373, lowest dose

Experimental group

Treatment:

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

KPS-0373, 2nd lowest dose

Experimental group

Treatment:

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

KPS-0373, 2nd highest dose

Experimental group

Treatment:

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

KPS-0373, highest dose

Experimental group

Treatment:

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

Drug: KPS-0373

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo