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Completed

NCT Number: NCT02939391

A Study of KW-6356 in Subjects With Early Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asahikawa, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KW-6356

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

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

    Time frame: Up to 12 weeks after dosing

Secondary outcomes

  1. Clinical global impression-improvement(CGI-I) score

    Time frame: Week 12

  2. Patient global impression-improvement(PGI-I) score

    Time frame: Week 12

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

    Time frame: Up to 12 weeks after dosing

  4. Number and percentage of subjects with treatment-emergent adverse events

    Time frame: Up to 14 weeks after dosing

  5. Profiles of pharmacokinetics of plasma KHK6356 concentration

    Time frame: 2, 4, 8 and 12 weeks after dosing

  6. Change from baseline in the MDS-UPDRS subitem and total scores

    Time frame: Up to 12 weeks after dosing

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2016
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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