18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

Newron Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: Safinamide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01286935

NW-1015/018/III/2006

2006-005861-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.

Enrollment

544 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
The patient was compliant with taking study medication in Study 016.
The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion criteria

The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.