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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01384435
• Date of registration: 23/06/2011
• Prospective Registration: No
• Primary sponsor: Kissei Pharmaceutical Co., Ltd.
• Public title: A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
• Scientific title: A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD
• Date of first enrolment: June 2011
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01384435
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Katsumi Hontani
• Affiliation: Clinical Research Dept.

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

SCD

Intervention(s)

Drug: Placebo

Drug: KPS-0373

Primary Outcome(s)

Change from baseline in Scale for the assessment and rating of ataxia (SARA) [Time Frame: 24 weeks]

Secondary Outcome(s)

Change from baseline in patient improvement impression of activities of daily living [Time Frame: 24 weeks]

Secondary ID(s)

KPS1203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors