Phase III study on FPF1100NW monotherapy
- Conditions
- Early Parkinson's disease
- Registration Number
- JPRN-jRCT2080221909
- Lead Sponsor
- FP Pharmaceutical Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 280
Main inclusion criteria
Parkinson's disease patients who have no history of previous treatment with anti-Parkinson's disease drugs
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 designated in the exclusion criteria 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 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 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
Patients who participated in any study using selegiline in the past
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change fom baseline in the sum of UPDRS part I, II and III
- Secondary Outcome Measures
Name Time Method (1) Change from baseline in each score of UPDRS part I, II, III and IV<br>(2) Change from baseline in the sum of UPDRS part II and III<br>(3) Proportion of responders defined with the sum of UPDRS part I, II and III<br>(4) Proportion of responders defined with the sum of UPDRS part II and III<br>(5) Modified Hoehn & Yahr rating stage<br>(6) Clinical Global Impression of Improvement (CGI-I)