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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00863538
First received: March 16, 2009
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Spinocerebellar Degeneration
Drug: KPS-0373
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Arms Assigned Interventions
Experimental: 1 Drug: KPS-0373

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SCD 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: NCT00863538

Locations
Japan
Japan
Hokkaido Region, Japan
Japan
Kansai Region, Japan
Japan
Kanto Region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00863538     History of Changes
Other Study ID Numbers: KPS1201
Study First Received: March 16, 2009
Last Updated: February 1, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Spinocerebellar degeneration
Thyrotropin-Releasing Hormone (TRH)
SCD

Additional relevant MeSH terms:
Spinocerebellar Degenerations
Cerebellar Ataxia
Cerebellar Diseases
Spinocerebellar Ataxias
Ataxia
Brain Diseases
Central Nervous System 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 October 29, 2014