Back to resultsExtended Long-Term Safety Study of KW-6500 (6500-005)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-6500
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Patients who have given written informed consent
- Patients who have completed the 6500-004 study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KW-6500
Arm Description
Outcomes
Primary Outcome Measures
Adverse events and related adverse events
Secondary Outcome Measures
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01063621
Brief Title
Extended Long-Term Safety Study of KW-6500
Acronym
6500-005
Official Title
Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection 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
January 2010 (undefined)
Primary Completion Date
August 2011 (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
This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.
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
27 (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 1 to 6 mg for the OFF state during 52 weeks
Primary Outcome Measure Information:
Title
Adverse events and related adverse events
Time Frame
From first administration of study drug through Study Week 52
Secondary Outcome Measure Information:
Title
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in 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 completed the 6500-004 study
Facility Information:
City
Toon
State/Province
Ehime
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Extended Long-Term Safety Study of KW-6500
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