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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 Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier:
NCT00955045
First received: August 4, 2009
Last updated: July 12, 2016
Last verified: July 2016
  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:


Further study details as provided by Kyowa Kirin Pharmaceutical Development, Inc.:

Study Start Date: August 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: istradefylline Drug: istradefylline

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Kirin Pharmaceutical Development, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00955045     History of Changes
Other Study ID Numbers: 6002-US-007 
Study First Received: August 4, 2009
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Kirin Pharmaceutical Development, 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
Istradefylline
Carbidopa
Levodopa
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016