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Completed

NCT Number: NCT00199355

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

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) 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

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

About this study

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time 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 40mg/d 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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/DCI for at least one year, stable dose in past 4 weeks.
  • Currently take at least three doses of levodopa/DCI per day.
  • Predictable end of dose wearing off.
  • Able to satisfactorily complete Hauser version of a Parkinson's diary.
  • Have an average of 120 minutes of OFF time on two 24 hour diaries.
  • On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
  • Be at least 30 years of age.

Exclusion criteria

  • Neurosurgical treatment for PD.
  • History of psychosis.
  • Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
  • Diagnosis of cancer within 5 years.
  • Diagnosis of clinically significant illness of any organ system.
  • Mini-mental status examination score of 25 or less.
  • Taking any excluded medications.
  • History of drug or alcohol abuse or dependence within the past two years.
  • History of seizures or neurological malignant syndrome.
  • Clinical depression.
  • Pregnant or lactating females.

Treatment and study plan

Istradefylline (KW-6002)

Drug

Primary outcomes

  1. To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.

Secondary outcomes

  1. To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.

  2. To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).

  3. To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).

  4. To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).

  5. To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).

  6. To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
May 23, 2014

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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