A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients
- Conditions
- Parkinson's disease with wearing off phenomenon
- Registration Number
- JPRN-jRCT2080222707
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 404
The participant has a diagnosis of Parkinson's disease according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank.
-The participant has Modified Hoehn & Yahr stage 2 to 4 (in the Off state).
-The participant has wearing off phenomenon and has been continuously receiving a levodopa combination drug for >= 6 months.
-The participant has been receiving a levodopa combination drug without change in the dose regimen (dosing frequency, at least 3 times a day).
-The participant has been receiving entacapone with a stable dose regimen.
-The participant has been receiving a dopamine agonist, anticholinergic drug, amantadine, droxidopa, istradefylline, or zonisamide with a stable dose regimen.
-The participant is an outpatient of either sex aged >= 30 and < 80 years.
-The participant has completed patient diary for at least 4 of the 7 days.
-The participant has mean daily off-time of >= 2.5 hours.
-The participant has unstable systemic disease.
-The participant has severe dyskinesia.
-The participant has Mini-Mental State Examination (MMSE) score of =< 24
-The participant has known or a history of schizophrenia, major or severe depression, or any other clinically significant psychiatric disease.
-The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever, herring, yeast, horsebean, banana, beer or wine).
-The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
-The participant has received transcranial magnetic stimulation within 6 months.
-The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days.
-The participant has received single agennt of levodopa, any psychoneurotic agent or antiemetic medication of dopamine agonist within 14 days. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days may be included in the study.
-The participant is required to take any of the excluded medications or treatments.
-The participant has laboratory data meeting any of the following:
-Creatinine >= 2 x upper limit of normal (ULN)
-Total bilirubin >= 2 x ULN
-ALT or AST >= 1.5 x ULN
-ALP >= 3 x ULN
-The participant has received any of the excludeded medications or treatments.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Change in the mean daily off-time<br>Timeframe: Up to 28 weeks
- Secondary Outcome Measures
Name Time Method