A 24-week Open-label 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:
NCT01970137
First received: October 22, 2013
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

Condition Intervention Phase
Spinocerebellar Degeneration
Drug: KPS-0373, High dose
Drug: KPS-0373, Low dose
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: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KPS-0373 Drug: KPS-0373, High dose Drug: KPS-0373, Low dose

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion Criteria:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
  • Discontinuations in another clinical trials caused by side effects
  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: NCT01970137

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: NCT01970137     History of Changes
Other Study ID Numbers: KPS1304 
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)

Additional relevant MeSH terms:
Spinocerebellar Degenerations
Spinocerebellar Ataxias
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cerebellar Ataxia
Ataxia
Dyskinesias
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016