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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-6500
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KW-6500

Arm Description

Outcomes

Primary Outcome Measures

The incidence of adverse events after administration of KW-6500
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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2009
Last Updated
March 14, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00955318
Brief Title
Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease
Official Title
Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KW-6500
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KW-6500
Other Intervention Name(s)
Apomorphine hydroshloride (USAN)
Intervention Description
Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state
Primary Outcome Measure Information:
Title
The incidence of adverse events after administration of KW-6500
Time Frame
From first administration of study drug through Study Week 52
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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

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