Phase II study on FPF1100NW monotherapy
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2080220987
- Lead Sponsor
- FP Pharmaceutical Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 90
Trial subjects
Parkinson's disease patients who have no history of previous treatment with anti-Parkinson's disease drugs
Main inclusion criteria
Within five years after onset of motor symptoms
Modified Hoehn & Yahr rating stage I - III
UPDRS part III total score 10 or greater
Main exclusion criteria
Patients taking the drugs prohibited from concomitant administration during a certain period of time before starting administration of the investigational drug
Patients complicated with serious neurological and mental disorders (e.g. disturbed consciousness, hallucination, delusion, abnormal behaviors, etc.)
Patients under the epilepsy treatment
Patients with advanced complications in the cardiovascular system, liver, kidney, blood or other organs
Patients with complication or history of schizophrenia
Patients with a dependence on CNS stimulants (e.g. amphetamines, cocaine, etc.) or with such history
Patients during pregnancy or lactation, or patients who wish to get pregnant during the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method