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A Phase II Double Blind Comparative 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:
NCT01384435
First received: June 23, 2011
Last updated: November 29, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).


Condition Intervention Phase
SCD
 Drug: KPS-0373
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in Scale for the assessment and rating of ataxia (SARA) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in patient improvement impression of activities of daily living [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Arms Assigned Interventions
Experimental: KPS-0373, lowest dose Drug: KPS-0373
Experimental: KPS-0373, 2nd lowest dose Drug: KPS-0373
Experimental: KPS-0373, 2nd highest dose Drug: KPS-0373
Experimental: KPS-0373, highest dose Drug: KPS-0373
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384435

Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsumi Hontani Clinical Research Dept.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01384435     History of Changes
Other Study ID Numbers: KPS1203
Study First Received: June 23, 2011
Last Updated: November 29, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Spinocerebellar degeneration (SCD)
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
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 May 23, 2013