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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863538
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : February 3, 2010
Information provided by:
Kissei Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Spinocerebellar Degeneration Drug: KPS-0373 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Arm Intervention/treatment
Experimental: 1 Drug: KPS-0373

Primary Outcome Measures :
  1. Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • SCD with mild to moderate ataxia

Exclusion Criteria:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863538

Hokkaido Region, Japan
Kansai Region, Japan
Kanto Region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd. Identifier: NCT00863538     History of Changes
Other Study ID Numbers: KPS1201
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

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

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
Neurologic Manifestations
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs