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A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

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: NCT03703570
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's disease on treatment with Levodopa-containing preparations as an adjunctive therapy.

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 : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations
Actual Study Start Date : September 29, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

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) part III score [ Time Frame: Up to 26 weeks after dosing ]

    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.

    The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).



Secondary Outcome Measures :
  1. Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state) [ Time Frame: Up to 26 weeks after dosing ]


Information from the National Library of Medicine

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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 2 to 4 on the Modified Hoehn and Yahr Scale. (mH&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
  • MDS-UPDRS partIII score of >= 15. (Evaluation at ON state)
  • Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
  • Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Exclusion Criteria:

  • Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
  • Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
  • Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
  • Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
  • Subject who have received administration of adenosine A2A receptor antagonist.
  • 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 subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.

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): NCT03703570


Locations
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Japan
Iwamizawa Neurology Clinic
Iwamizawa, Hokkaido, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03703570    
Other Study ID Numbers: 6356-003
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020

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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
Synucleinopathies
Neurodegenerative Diseases