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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00957203
First received: August 7, 2009
Last updated: August 30, 2012
Last verified: August 2012

August 7, 2009
August 30, 2012
October 2009
September 2011   (final data collection date for primary outcome measure)
Adverse events [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957203 on ClinicalTrials.gov Archive Site
  • Reducing the mean total hours of awake time per day spent in the OFF state [ Designated as safety issue: No ]
  • Reducing the mean percentage of awake time per day spent in the OFF state [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression - Improvement scale (CGI-I) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Other Name: KW-6002
Experimental: Istradefylline
Intervention: Drug: Istradefylline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
March 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00957203
6002-010
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP