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

Sponsor
Kyowa Kirin, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00955045
Collaborator
(none)
1
Location
1
Arm
14
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
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
Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
Oct 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: istradefylline

Drug: istradefylline

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 48 Centers in the US and 4 in Canada Princeton New Jersey United States 08540

    Sponsors and Collaborators

    • Kyowa Kirin, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00955045
    Other Study ID Numbers:
    • 6002-US-007
    First Posted:
    Aug 7, 2009
    Last Update Posted:
    Jul 13, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by , ,
    long-term tolerability and safety
    istradefylline treatment
    levodopa/carbidopa
    Additional relevant MeSH terms:
    Parkinson Disease
    Istradefylline

    Study Results

    No Results Posted as of Jul 13, 2016