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6002-010: Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00957203
Collaborator
(none)
308
Enrollment
1
Location
1
Arm
29
Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
308 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Istradefylline

Drug: Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Other Names:
  • KW-6002

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events []

    Secondary Outcome Measures

    1. Reducing the mean total hours of awake time per day spent in the OFF state []

    2. Reducing the mean percentage of awake time per day spent in the OFF state []

    3. Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia) []

    4. Change in Unified Parkinson's Disease Rating Scale (UPDRS) []

    5. Change in the Clinical Global Impression - Improvement scale (CGI-I) []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Be willing and able to give written informed consent

    2. Completion of the study 6002-009

    Exclusion Criteria:

    1. Mini-mental status examination score of 23 or less

    2. Less than 70% of compliance in the study 6002-009

    3. Emergency deviation in the study 6002-009

    4. Pregnant females

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tokyo Japan

    Sponsors and Collaborators

    • Kyowa Kirin Co., Ltd.

    Investigators

    • Study Director: Study Director, Kyowa Kirin Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Kirin Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT00957203
    Other Study ID Numbers:
    • 6002-010
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Aug 31, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Kyowa Kirin Co., Ltd.
    Parkinson's disease
    levodopa
    end of dose wearing off
    OFF time
    Additional relevant MeSH terms:
    Parkinson Disease
    Istradefylline

    Study Results

    No Results Posted as of Aug 31, 2012