Clinical trial NCT00456586: 12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Levodopa therapy
End of dose wearing off
Off time
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.

Detailed description: A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.

Eligibility criteria: Inclusion Criteria:

1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
2. Modified Hoehn and Yahr Scale II-IV in the OFF state.
3. Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
4. Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
5. Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
6. Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
7. At least 30 years of age and able to give written informed consent.

Exclusion Criteria:

1. Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
2. Treatment with MAO inhibitors except selegiline.
3. Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
4. Neurosurgical surgery for Parkinson's disease.
5. Atypical parkinsonism or secondary parkinsonism variants.
6. Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
7. Mini-Mental Status Examination score of 25 or less.
8. History of drug or alcohol abuse or dependence within 2 years.
9. History of psychotic illness or seizures.
10. Current clinically relevant depression disorder.
11. History of neuroleptic malignant syndrome.
12. Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.

Primary outcomes:
measure: To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary outcomes:
measure: To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Contact Kyowa Pharmacuetical Inc.
state: New Jersey
Study officials:
affiliation: Kyowa Kirin, Inc.
name: Neil Sussman, MD
role: STUDY_DIRECTOR
References: