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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified March 2024 by Kyowa Kirin, Inc.
Sponsor
Kyowa Kirin, Inc.
Information Provided by (Responsible Party)
Kyowa Kirin, Inc.
Clinicaltrials.gov Identifier
NCT00199368
Other Study ID Numbers:
6002-INT-001
First Submitted
September 11, 2005
First Posted
September 19, 2005
Last Update Posted
April 24, 2024
Last Verified
March 2024

ClinicalTrials.gov processed this data on April 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Parkinson's Disease

Study Design

Study TypeInterventional
Actual Enrollment1100 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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.
Study Start DateSeptember 30, 2004
Actual Primary Completion DateFebruary 28, 2007
Actual Study Completion DateApril 30, 2007

Outcome Measures

Primary Outcome Measures
  1. Safety
Secondary Outcome Measures
  1. Safety

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsKyowa Kirin, Inc.
Locations
Kyowa Pharmaceutical Inc. | Princeton New Jersey, United States, 08540
Investigators
Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.