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

NCT01970098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2018-12-14

No results posted yet for this study

Summary

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

Conditions

  • Spinocerebellar Degeneration

Interventions

DRUG

KPS-0373, High dose

28 weeks

DRUG

KPS-0373, Low dose

28 weeks

DRUG

Placebo

28 weeks

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tatsuro Takei

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-09
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970098 on ClinicalTrials.gov