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A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

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ClinicalTrials.gov Identifier: NCT03845387
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date February 19, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score [ Time Frame: 12 weeks ]
Change from baseline (Week 0) in MDS-UPDRS total score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score [ Time Frame: 12 weeks ]
    Change from baseline (Week 0) in PDQ-39 summary index score
  • Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score [ Time Frame: 12 weeks ]
    Change from baseline (Week 0) in PDSS-2 total score
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 A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Official Title  ICMJE A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Brief Summary Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: KDT-3594
    oral administration, dose titration
  • Drug: Pramipexole
    ER formulation, oral administration, dose titration
Study Arms  ICMJE
  • Experimental: KDT-3594
    Intervention: Drug: KDT-3594
  • Pramipexole
    Reference drug
    Intervention: Drug: Pramipexole
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese patients
  • Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  • Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion Criteria:

  • Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
  • Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
  • Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kissei Pharmaceutical Co., Ltd Email only rinsyousiken@pharm.kissei.co.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03845387
Other Study ID Numbers  ICMJE KDT1201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 Kissei Pharmaceutical Co., Ltd.
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date February 2019

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