A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: Istradefylline (KW-6002)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00199420

6002-US-018

Details and patient eligibility

About

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Full description

To establish the efficacy of 10, 20 and 40 mg/d dose 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 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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/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.

Exclusion criteria

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.