Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

Phase 3

Completed

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

• Registration Number: NCT00642889
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief Summary

To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.

Detailed Description

The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-01
• Study Completion: 2007-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Last Update Submitted: 2008-03-21
• Study First Posted: 2008-03-25
• Last Update Posted: 2008-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

1. The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
2. The patient was compliant with taking study medication in Study 015.
3. The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria

1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
2. The patient has shown clinically significant deterioration during participation in Study 015.
3. The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Safinamide	50-100mg/day
Placebo	Placebo	-
High Dose	Safinamide	150-200mg/day

Primary Outcome Measures

Name	Time	Method
Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur