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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.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: KDT-3594 Drug: Pramipexole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KDT-3594 Drug: KDT-3594
oral administration, dose titration

Pramipexole
Reference drug
Drug: Pramipexole
ER formulation, oral administration, dose titration




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03845387


Contacts
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Contact: Kissei Pharmaceutical Co., Ltd Email only rinsyousiken@pharm.kissei.co.jp

Locations
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Japan
Research Site Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Nobuo Kanai Kissei Pharmaceutical Co., Ltd.

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03845387     History of Changes
Other Study ID Numbers: KDT1201
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents