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A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00955045
First received: August 4, 2009
Last updated: August 5, 2009
Last verified: August 2009
History of Changes
  Purpose

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.


Condition Intervention Phase
Parkinson's Disease
 Drug: istradefylline
 Phase 2
Phase 3

Study Type: Interventional
Official Title: A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Study Start Date: August 2002
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: istradefylline Drug: istradefylline

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible subjects were:

  • male or female
  • at least 30 years of age
  • had completed participation in a prior double-blind istradefylline trial
  • met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
  • had been treated with levodopa for at least 1 year
  • had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
  • were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
  • had predictable end-of-dose wearing-off

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955045

Locations
United States, New Jersey
48 Centers in the US and 4 in Canada
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00955045     History of Changes
Other Study ID Numbers: 6002-US-007
Study First Received: August 4, 2009
Last Updated: August 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
long-term tolerability and safety
istradefylline treatment
levodopa/carbidopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Istradefylline
Antiparkinson Agents
Anti-Dyskinesia Agents
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on May 19, 2013