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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Apomorphine

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