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

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Spinocerebellar Degeneration Clinical Trial

Official title:
An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Status Completed

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.

n/a

NCT number	NCT02889302
Study type	Interventional
Source	Kissei Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	November 15, 2016
Completion date	March 2018

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	`NCT01970137` - A 24-week Open-label 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	`NCT01970124` - A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)	Phase 3
Completed	`NCT01004016` - A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)	Phase 2