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

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Key facts

Study ID

NCT00199407

Run by

Kyowa Kirin, Inc.

People needed

230

Starts

2004-06-01

Expected to finish

2006-01-01

Last updated by the study team

2024-04-25

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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/carbidopa for at least one year, stable dose in past 4 weeks.
• Currently take at least three doses of levodopa/carbidopa per day.
• Predictable end of dose wearing off.
• Able to satisfactorily complete Hauser version of a Parkinson's diary.
• Have an average of 180 minutes of OFF time on two 24 hour diaries.
• Be at least 30 years of age.

You may not qualify if…

• Neurosurgical treatment for PD.
• History of psychosis.
• Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
• Diagnosis of cancer within 5 years.
• Mini-mental status examination score of 25 or less.
• History of seizures or neurologic malignant_syndrome.
• Clinical depression.

Where it is running

• Kyowa Pharmaceutical Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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