Parkinson's Disease
Conditions
Keywords
Parkinson's disease, levodopa, end of dose wearing off, OFF time
Brief summary
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.
Detailed description
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 40mg/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.
Interventions
DRUGIstradefylline
Two 10 mg KW-6002 tablets orally once daily for 12 weeks
DRUGPlacebo
Two placebo tablets orally once daily for 12 weeks
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD. 2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. 3. On levodopa/dopa-decarboxylase inhibitor for at least one year. 4. Taking at least three doses and \>=300mg of levodopa per day for at least four weeks before randomization. 5. Predictable end of dose wearing off. 6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary. 7. Have an average of two hours of OFF time on 24-hour diaries. 8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization. 9. Be at least 20 years of age. 10. Be willing and able to give written informed consent.
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 25 or less. 6. History of drug or alcohol abuse or dependence within the past two years. 7. History of psychosis. 8. Significant drug allergies. 9. Taking anticonvulsants for seizures. 10. History of neurological malignant syndrome. 11. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. | Last Visit |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state. | Every Visit |
| To evaluate 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). | Every Visit |
| To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). | Every Visit |
| To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). | Visit 4 and Last Visit |
| To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline | Every Visit |
Countries
Japan
Outcome results
None listed