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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
History of Changes
  Purpose

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 Intervention Phase
Parkinson's Disease
 Drug: Istradefylline
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 308
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Istradefylline Drug: Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Other Name: KW-6002

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957203

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00957203     History of Changes
Other Study ID Numbers: 6002-010
Study First Received: August 7, 2009
Last Updated: August 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Parkinson's disease
levodopa
end of dose wearing off
OFF time

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Istradefylline
 Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013