ong-term study of FPF1100NW monotherapy

Phase 2

• Conditions: Early Parkinson's disease

• Registration Number: JPRN-jRCT2080221954
• Lead Sponsor: FP Pharmaceutical Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 130

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from 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)