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An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

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Kyowa Kirin

Status and phase

Terminated
Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: Istradefylline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00199381
6002-US-025

Details and patient eligibility

About

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Full description

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Enrollment

504 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of study 6002-INT-001
  • Not of childbearing potential

Exclusion criteria

  • Cancer within 5 years of enrollment
  • ALT/AST levels > 2.5 times ULN

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

504 participants in 1 patient group

Single Arm
Experimental group
Description:
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
Treatment:
Drug: Istradefylline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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