Status:

COMPLETED

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

Lead Sponsor:

Kyowa Kirin Co., Ltd.

Conditions:

Parkinson's Disease

Eligibility:

All Genders

20+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • Be willing and able to give written informed consent
  • Completion of the study 6002-009

Exclusion

  • Mini-mental status examination score of 23 or less
  • Less than 70% of compliance in the study 6002-009
  • Emergency deviation in the study 6002-009
  • Pregnant females

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

308 Patients enrolled

Trial Details

Trial ID

NCT00957203

Start Date

October 1 2009

End Date

March 1 2012

Last Update

August 31 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tokyo, Japan