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12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

NCT00456794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2024-04-25

No results posted yet for this study

Summary

A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.

Conditions

Interventions

DRUG

Istradefylline (KW-6002)

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Neil Sussman, MD · Kyowa Kirin, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00456794 on ClinicalTrials.gov