Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 (6500-004)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-6500
KW-6500 Placebo
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 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 Unified Parkinson's Disease Rating Scale (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 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
- Ehime University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KW-6500
KW-6500 Placebo
Arm Description
Outcomes
Primary Outcome Measures
The raw score change in UPDRS part III score
Secondary Outcome Measures
The percent score change in UPDRS part III score and response ratio
Full Information
NCT ID
NCT01058291
First Posted
January 27, 2010
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01058291
Brief Title
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
Acronym
6500-004
Official Title
Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (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 placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-6500
Arm Type
Experimental
Arm Title
KW-6500 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KW-6500
Other Intervention Name(s)
Apomorphine hydroshloride (USAN)
Intervention Description
Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
Intervention Type
Drug
Intervention Name(s)
KW-6500 Placebo
Intervention Description
Twelve weeks subcutaneous injection for the OFF state
Primary Outcome Measure Information:
Title
The raw score change in UPDRS part III score
Time Frame
At the double blind period
Secondary Outcome Measure Information:
Title
The percent score change in UPDRS part III score and response ratio
Time Frame
At the double blind period
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 Unified Parkinson's Disease Rating Scale (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 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:
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
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