An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199368

Enrollment

1100

Registered

2005-09-20

Start date

2004-10-31

Completion date

2007-05-31

Last updated

2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, levodopa, end of dose wearing off, OFF time

Brief summary

This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Detailed description

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Interventions

DRUGIstradefylline ( KW-6002)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018 * Non-pregnant and either not of childbearing potential or using specified contraception

Exclusion criteria

* History of psychotic illness * Variant/atypical Parkinson's disease * Cancer within 5 years of enrollment * ALT/AST levels \> 1.5 times ULN * Seizure disorder * Neuroleptic malignant syndrome

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Safety	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026