NCT02939391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

October 17, 2016

Last Update Submit

March 19, 2018

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score

    Up to 12 weeks after dosing

Secondary Outcomes (6)

  • Clinical global impression-improvement(CGI-I) score

    Week 12

  • Patient global impression-improvement(PGI-I) score

    Week 12

  • Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores

    Up to 12 weeks after dosing

  • Number and percentage of subjects with treatment-emergent adverse events

    Up to 14 weeks after dosing

  • Profiles of pharmacokinetics of plasma KHK6356 concentration

    2, 4, 8 and 12 weeks after dosing

  • +1 more secondary outcomes

Study Arms (3)

KW-6356 Low Dose

EXPERIMENTAL

Oral administration

Drug: KW-6356

KW-6356 High Dose

EXPERIMENTAL

Oral administration

Drug: KW-6356

Placebo

PLACEBO COMPARATOR

Oral administration

Drug: Placebo

Interventions

KW-6356DRUG

Oral administration

KW-6356 Low Dose
PlaceboDRUG

Oral administration

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Asahikawa, Hokkaido, Japan

Location

Unknown Facility

Akashi, Hyōgo, Japan

Location

Unknown Facility

Fujisawa, Kanagawa, Japan

Location

Unknown Facility

Suita, Osaka, Japan

Location

Unknown Facility

Nakano City, Tokyo, Japan

Location

Unknown Facility

Setagaya City, Tokyo, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Related Publications (1)

  • Maeda T, Kimura T, Sugiyama K, Yamada K, Hiraiwa R, Nishi M, Hattori N; 6356-002 study group. Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease. Parkinsonism Relat Disord. 2023 Dec;117:105907. doi: 10.1016/j.parkreldis.2023.105907. Epub 2023 Oct 31.

    PMID: 37948832DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 20, 2016

Study Start

September 1, 2016

Primary Completion

November 22, 2017

Study Completion

December 8, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(7)