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A Study of KW-6356 in Subjects With Early Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02939391
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: KW-6356 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KW-6356 Low Dose
Oral administration
Drug: KW-6356
Oral administration

Experimental: KW-6356 High Dose
Oral administration
Drug: KW-6356
Oral administration

Placebo Comparator: Placebo
Oral administration
Drug: Placebo
Oral administration




Primary Outcome Measures :
  1. Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score [ Time Frame: Up to 12 weeks after dosing ]

Secondary Outcome Measures :
  1. Clinical global impression-improvement(CGI-I) score [ Time Frame: Week 12 ]
  2. Patient global impression-improvement(PGI-I) score [ Time Frame: Week 12 ]
  3. Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores [ Time Frame: Up to 12 weeks after dosing ]
  4. Number and percentage of subjects with treatment-emergent adverse events [ Time Frame: Up to 14 weeks after dosing ]
  5. Profiles of pharmacokinetics of plasma KHK6356 concentration [ Time Frame: 2, 4, 8 and 12 weeks after dosing ]
  6. Change from baseline in the MDS-UPDRS subitem and total scores [ Time Frame: Up to 12 weeks after dosing ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
  • Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
  • MDS-UPDRS part III score of ≥ 15

Exclusion Criteria:

  • Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
  • Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period.
  • Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more.
  • Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS).
  • Either of the following criteria consecutively at screening and enrollment;

    • Resting Pulse > 100 bpm
    • Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg
  • Significant dementia or a Mini-Mental State Examination (MMSE) score of ≤ 23.
  • Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
  • Anyone otherwise considered unsuitable for the study by the investigator or sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.

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): NCT02939391


Locations
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Japan
Asahikawa City, Hokkaido, Japan
Akashi, Hyogo, Japan
Fujisawa, Kanagawa, Japan
Suita, Osaka, Japan
Nakano, Tokyo, Japan
Setagaya, Tokyo, Japan
Kyoto, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02939391     History of Changes
Other Study ID Numbers: 6356-002
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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