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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Istradefylline ( KW-6002)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, end of dose wearing off, OFF time

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kyowa Pharmaceutical Inc.

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00199368

First Posted

September 12, 2005

Last Updated

July 12, 2016

Sponsor

Kyowa Kirin, Inc.

Collaborators

Kyowa Hakko Kirin UK, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00199368

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kyowa Kirin, Inc.

Collaborators

Kyowa Hakko Kirin UK, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Istradefylline ( KW-6002)

Primary Outcome Measure Information:

Title

Safety

Secondary Outcome Measure Information:

Title

Safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Sussman, MD

Organizational Affiliation

Kyowa Kirin, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Kyowa Pharmaceutical Inc.

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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