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

This study has been completed.

Sponsor:

Collaborator:

Kyowa Hakko Kirin UK, Ltd.

Information provided by:

Kyowa Hakko Kirin Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT00199368

First received: September 12, 2005

Last updated: June 22, 2010

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 22, 2010

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00199368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Istradefylline ( KW-6002)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1100

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00199368

Other Study ID Numbers ^ICMJE

6002-INT-001

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Kyowa Hakko Kirin Pharma, Inc.

Collaborators ^ICMJE

Kyowa Hakko Kirin UK, Ltd.

Investigators ^ICMJE

Study Director:

Neil Sussman, MD

Kyowa Hakko Kirin Pharma, Inc.

Information Provided By

Kyowa Hakko Kirin Pharma, Inc.

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top