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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Safinamide; Drug: Placebo

• Registration Number: NCT01286935
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2010-04
• Study Completion: 2010-08
• Study First Submitted: 2010-08-23
• Status Verified: 2011-01
• Study First Submitted QC: 2011-01-28
• Last Update Submitted: 2011-01-28
• Study First Posted: 2011-01-31
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 544

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose (50mg/day)	Safinamide	-
Placebo	Placebo	-
High Dose (100mg/day)	Safinamide	-

Primary Outcome Measures

Name	Time	Method
Mean change in the dyskinesias rating scale (DRS) during "on" time	Up to 104 weeks (from baseline 016 to EOS study 018)	mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).

Secondary Outcome Measures

Name	Time	Method
Endpoints include 'ON time', responder rates and UPDRS IV change	Up to 104 weeks (from baseline 016 to EOS study 018)	* Chge in ON time (ON+ON minor dysk),; * Diary Resp Rate at 12-m, 18 \& 24 m on the ITT\&mITT pop\&pts who completed 2-yr period; * UPDRS IV chge in total score,items 32-35 \& 32-34; * Time develop tblsome dysk(\> 30min incr of tblsome dysk); * Time develop any (minor \&/or tblsome) dysk (\> 30 min incr of dysk); * Chge ADLs during ON, vs pbo(UPDRS II); * Maintenance of effect in UPDRS II "resp'(resp \>=20% impr in ADLs).; * chge in L-dopa dose; * chge in any PD(other than L-dopa)drug dose; * Chge in UPDRS III, CGI-C and CGI-S; * Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)