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An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00199368
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
Kyowa Hakko Kirin UK, Ltd.
Information provided by:
Kyowa Kirin Pharmaceutical Development, Inc.

Study Description
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Brief Summary:
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Istradefylline ( KW-6002) Phase 3

Detailed Description:
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
Study Start Date : October 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : May 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Safety

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
  • Non-pregnant and either not of childbearing potential or using specified contraception

Exclusion Criteria:

  • History of psychotic illness
  • Variant/atypical Parkinson's disease
  • Cancer within 5 years of enrollment
  • ALT/AST levels > 1.5 times ULN
  • Seizure disorder
  • Neuroleptic malignant syndrome
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199368


Locations
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United States, New Jersey
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Kyowa Hakko Kirin UK, Ltd.
Investigators
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Study Director: Neil Sussman, MD Kyowa Kirin Pharmaceutical Development, Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00199368    
Other Study ID Numbers: 6002-INT-001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
Parkinson's disease
levodopa
end of dose wearing off
OFF time
Additional relevant MeSH terms:
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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
Physiological Effects of Drugs