Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration

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.

Status Completed

Clinical Trial Summary

To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

n/a

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

NCT number	NCT00863538
Study type	Interventional
Source	Kissei Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 2

See also
Status	Clinical Trial	Phase
Completed	`NCT01970098` - A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)	Phase 3
Completed	`NCT02889302` - An Additional 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	`NCT01004016` - A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)	Phase 2
Completed	`NCT01970111` - An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)	Phase 3
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