Clinical trial NCT01058291: Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
Official title: Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The raw score change in UPDRS part III score
timeFrame: At the double blind period
Secondary outcomes:
measure: The percent score change in UPDRS part III score and response ratio
timeFrame: At the double blind period
Other outcomes:
Locations:
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
Study officials:
References: