Clinical trial NCT02939391: A Study of KW-6356 in Subjects With Early Parkinson's Disease
Official title: An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
timeFrame: Up to 12 weeks after dosing
Secondary outcomes:
measure: Clinical global impression-improvement(CGI-I) score
timeFrame: Week 12
measure: Patient global impression-improvement(PGI-I) score
timeFrame: Week 12
measure: Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
timeFrame: Up to 12 weeks after dosing
measure: Number and percentage of subjects with treatment-emergent adverse events
timeFrame: Up to 14 weeks after dosing
measure: Profiles of pharmacokinetics of plasma KHK6356 concentration
timeFrame: 2, 4, 8 and 12 weeks after dosing
measure: Change from baseline in the MDS-UPDRS subitem and total scores
timeFrame: Up to 12 weeks after dosing
Other outcomes:
Locations:
city: Asahikawa City
country: Japan
state: Hokkaido
city: Akashi
country: Japan
state: Hyogo
city: Fujisawa
country: Japan
state: Kanagawa
city: Suita
country: Japan
state: Osaka
city: Nakano
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Kyoto
country: Japan
Study officials:
References: