Parkinson's Disease
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be willing and able to give written informed consent 2. UK Parkinson's Disease Society 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 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 patient Parkinson's diaries 9. On a stable regimen of any other anti-Parkinson's drugs 10. On a stable dose of domperidone
Exclusion criteria
Exclusion criteria: 1. Taking any excluded medications 2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD 3. Diagnosis of cancer 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 7. History of psychosis 8. History of 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 |
|---|---|
| Efficacy: 24-hour patient Parkinson's diaries | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: adverse events | — |
Outcome results
None listed