Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease

March 14, 2017 updated by: Kyowa Kirin Co., Ltd.

Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have given written informed consent
  • Patients who have Parkinson's disease
  • Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
  • Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
  • Patients who have experienced a 30% or more improvement in UPDRS partⅢ score when tested for responsiveness to levodopa during the baseline period
  • Patients who have at least one OFF state per day
  • Patients who can understand the expression of OFF state, ON state, and dyskinesia
  • Patients or their families have a desire for self-injection of KW-6500

Exclusion Criteria:

  • Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
  • Patients with orthostatic hypotension
  • Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
  • Patients with a history of malignant syndrome
  • Patients with a diagnosis of cancer or evidence of continued disease
  • Patients who do not test negative in the direct Coombs' test
  • Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
  • Patients who have received MAO inhibitors except selegiline
  • Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
  • Patients with a Mini-Mental State Examination (MMSE) score of 23 or less
  • Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
  • Patients who are receiving methyldopa or 5-HT3 receptor antagonists
  • Patients who are receiving reserpine or papaverine
  • Patients who have had a neurosurgical operation for Parkinson's disease
  • Patients who have had transcranial magnetic stimulation
  • Patients with a history of drug or alcohol abuse or dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KW-6500
Drug: KW-6500
Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state
Other Names:
  • Apomorphine hydroshloride (USAN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse events after administration of KW-6500
Time Frame: From first administration of study drug through Study Week 52
From first administration of study drug through Study Week 52
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in Unified Parkinson's Disease Rating Scale (UPDRS) part III, response ratio, and UPDRS part II score
Time Frame: From first administration of study drug through Study Week 52
From first administration of study drug through Study Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6500-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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