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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Kissei Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01970124
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients


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: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-8 (QOL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Japanese SCD patients with 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: NCT01970124

Contacts
Contact: Kissei Pharmaceutical Co., Ltd rinsyousiken@pharm.kissei.co.jp

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

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970124     History of Changes
Other Study ID Numbers: KPS1303
Study First Received: October 22, 2013
Last Updated: October 22, 2013
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
Cerebellar Diseases
Cerebellar Ataxia
Spinocerebellar Ataxias
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Ataxia
Dyskinesias
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014