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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01970098
First received: October 22, 2013
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Spinocerebellar Degeneration
Drug: KPS-0373, High dose
Drug: KPS-0373, Low dose
Drug: Placebo
Phase 3

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-8 (QOL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KPS-0373 Drug: KPS-0373, High dose Drug: KPS-0373, Low dose
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970098

Locations
Japan
Tokyo and Other Japanese Cities, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970098     History of Changes
Other Study ID Numbers: KPS1301 
Study First Received: October 22, 2013
Last Updated: April 15, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Spinocerebellar Ataxia (SCA)
Cortical Cerebellar Atrophy (CCA)

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Ataxia
Brain Diseases
Central Nervous System Diseases
Cerebellar Ataxia
Cerebellar Diseases
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Spinal Cord Diseases

ClinicalTrials.gov processed this record on May 23, 2016