A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Parkinson's Disease Clinical Trial

Official title:

A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955045
• Other study ID #: 6002-US-007
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2002
• Est. completion date: October 2003

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

Eligible subjects were:

• male or female

• at least 30 years of age

• had completed participation in a prior double-blind istradefylline trial

• met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state

• had been treated with levodopa for at least 1 year

• had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline

• were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)

• had predictable end-of-dose wearing-off

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• istradefylline

Locations

Country	Name	City	State
United States	48 Centers in the US and 4 in Canada	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.

Country where clinical trial is conducted

United States,