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

An Additional Confirmatory 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: NCT02889302
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE September 5, 2016
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE November 15, 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 24 weeks ]
The change in the SARA total score at the time of final evaluation
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
SF-8(QOL) [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official Title  ICMJE An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Brief Summary The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spinocerebellar Degeneration
Intervention  ICMJE
  • Drug: KPS-0373
    24 weeks
  • Drug: Placebo
    24 weeks
Study Arms  ICMJE
  • Experimental: KPS-0373
    Intervention: Drug: KPS-0373
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2018)
203
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02889302
Other Study ID Numbers  ICMJE KPS1305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nobuo Kanai
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP