Clinical trial NCT03703570: A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
Official title: A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 502
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score
timeFrame: Up to 26 weeks after dosing
Secondary outcomes:
measure: 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)
timeFrame: Up to 26 weeks after dosing
Other outcomes:
Locations:
city: Iwamizawa
country: Japan
facility: Iwamizawa Neurology Clinic
state: Hokkaido
Study officials:
References: