Early Parkinson's disease
Conditions
Sponsors
FP Pharmaceutical Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Patients who completed Phase III study on FPF1100NW monotherapy for treatment of early Parkinson's disease Patients who can come to the hospital based on the investigator's or subinvestigator's suggestion Patients who can receive the examinations designated in this study Patients who submitted the informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients who took the drugs prohibited from concomitant administration (except FPF1100NW) after commencement of Phase III study on FPF1100NW monotherapy Patients during pregnancy or lactation, or patients who wish to get pregnant during the study Patients judged inappropriate by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the sum of UPDRS part I, II and III | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in each score of UPDRS part I, II, III and IV (2) Change from baseline in the sum of UPDRS part II and III (3) Proportion of responders defined with the sum of UPDRS part I, II and III (4) Proportion of responders defined with the sum of UPDRS part II and III (5) Modified Hoehn & Yahr rating stage (6) Clinical Global Impression of Improvement (CGI-I) | — |
Outcome results
None listed