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

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ClinicalTrials.gov Identifier: NCT01004016
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: KPS-0373 Drug: KPS-0373


Outcome Measures
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Primary Outcome Measures :
  1. Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: 4 weeks + 12 weeks ]
  2. Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01004016


Locations
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Japan
Japan
Japan, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Yasuhiro Omori Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
More Information
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ClinicalTrials.gov Identifier: NCT01004016     History of Changes
Other Study ID Numbers: KPS1202
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
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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