Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 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.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Japan
Japan
Japan, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Yasuhiro Omori Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT01004016    
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:
Layout table for 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