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Completed

NCT Number: NCT00955526

Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

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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
  • UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
  • PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
  • On levodopa/dopa-decarboxylase inhibitor for at least one year
  • Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
  • Predictable end of dose wearing off
  • Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
  • Have an average of two hours of OFF time on 24-hour diaries
  • On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
  • On a stable dose of domperidone for at least 14 days before randomization

Exclusion criteria

  • Taking any excluded medications
  • Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
  • Diagnosis of cancer within 5 years
  • Diagnosis of clinically significant illness of any organ system
  • Diagnosis of dementia or mini-mental status examination score of 23 or less
  • History of drug or alcohol abuse or dependence within the past two years
  • History of psychosis
  • History of significant drug allergies
  • Taking anticonvulsants for seizures
  • History of neuroleptic malignant syndrome
  • Pregnant or lactating females

Treatment and study plan

Istradefylline

Drug

20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)

Other names: KW-6002

Placebo

Drug

Two placebo tablets once daily for 12 weeks

Primary outcomes

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

Secondary outcomes

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

  2. 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)

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

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

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Acronym: 6002-009

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2009
Registry last updated
Aug 29, 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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