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Completed

NCT Number: NCT00199368

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, 08540, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Istradefylline ( KW-6002)

Drug

Primary outcomes

  1. Safety

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Collaborators

  • Kyowa Hakko Kirin UK, Ltd.

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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