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

NCT00456586 | Completed Phase 2

• 1 other identifier: 6002-US-005
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Levodopa therapy; End of dose wearing off; Off time

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

KW-6002 (istradefylline) DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
• Treatment with MAO inhibitors except selegiline.
• Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
• Neurosurgical surgery for Parkinson's disease.
• Atypical parkinsonism or secondary parkinsonism variants.
• 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).
• Mini-Mental Status Examination score of 25 or less.
• History of drug or alcohol abuse or dependence within 2 years.
• History of psychotic illness or seizures.
• Current clinically relevant depression disorder.
• History of neuroleptic malignant syndrome.
• Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (1)

Contact Kyowa Pharmacuetical Inc.

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Neil Sussman, MD

  Kyowa Kirin, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: April 1, 2002
• Primary Completion: May 1, 2003
• Study Completion: June 1, 2003
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)