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Completed

NCT Number: NCT00957203

Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

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.

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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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be willing and able to give written informed consent
  • Completion of the study 6002-009

Exclusion criteria

  • Mini-mental status examination score of 23 or less
  • Less than 70% of compliance in the study 6002-009
  • Emergency deviation in the study 6002-009
  • Pregnant females

Treatment and study plan

Istradefylline

Drug

Oral istradefylline (KW-6002) 20 or 40 mg once daily

Other names: KW-6002

Primary outcomes

  1. Adverse events

Secondary outcomes

  1. Reducing the mean total hours of awake time per day spent in the OFF state

  2. Reducing the mean percentage of awake time per day spent in the OFF state

  3. 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)

  4. Change in Unified Parkinson's Disease Rating Scale (UPDRS)

  5. Change in the Clinical Global Impression - Improvement scale (CGI-I)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Acronym: 6002-010

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 12, 2009
Registry last updated
Aug 31, 2012

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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