Status:
COMPLETED
Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 complication...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00955318
Start Date
July 1 2009
End Date
March 1 2012
Last Update
March 15 2017
Active Locations (1)
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1
Tokyo, Japan