Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa (6002-009)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: Istradefylline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955526

6002-009

Details and patient eligibility

About

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.

Enrollment: 373 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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373 participants in 3 patient groups, including a placebo group

Istradefylline 20mg

Experimental group

Treatment:

Drug: Istradefylline

Drug: Istradefylline

Istradefylline 40mg

Experimental group

Treatment:

Drug: Istradefylline

Drug: Istradefylline

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo