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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02889302
Other study ID # KPS1305
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 15, 2016
Est. completion date March 2018

Study information

Verified date December 2018
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Drug:
KPS-0373
24 weeks
Placebo
24 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary SARA (Scale for the Assessment and Rating of Ataxia) The change in the SARA total score at the time of final evaluation 24 weeks
Secondary SF-8(QOL) 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT01970098 - A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 3
Completed NCT04107740 - C-Trelin Orally Disintegrated(OD) Tablet 5mg in Ataxia Due to Spinocerebellar Degeneration Phase 4
Completed NCT01970111 - An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 3
Completed NCT00863538 - Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 2
Completed NCT01004016 - A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 2
Completed NCT01970124 - A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 3
Completed NCT01970137 - A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) Phase 3