Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 (6500-004)

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: KW-6500 Placebo

Drug: KW-6500

Study type

Interventional

Funder types

Industry

Identifiers

NCT01058291

6500-004

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

20+ years old

Volunteers

No 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 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