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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03703570 |
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Date of registration:
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05/10/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
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Scientific title:
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A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations |
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Date of first enrolment:
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September 29, 2018 |
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Target sample size:
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502 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03703570 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: KW-6356
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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