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

Phase 3

Completed

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

• Registration Number: NCT00643045
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief Summary

To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as 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 agonist. It is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-01
• Study Completion: 2007-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-24
• Last Update Submitted: 2008-03-24
• Study First Posted: 2008-03-25
• Last Update Posted: 2008-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• Patients with a diagnosis of idiopathic Parkinson's disease of less than 5 years duration, and a Hoehn and Yahr Stage of I to III,
• who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to Visit 1 (Screening).

Exclusion Criteria

• Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
• patients with a diagnosis or recent history of substance abuse,
• a history of psychosis,
• who were depressed,
• had evidence of dementia or cognitive dysfunction,
• or who were experiencing end of dose wearing-off;
• female patients of childbearing potential;
• patients who have previously received safinamide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Safinamide	Low dose (50-100mg/day)
2	Safinamide	High dose (150-200 mg/day)
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).	24 weeks

Secondary Outcome Measures

Name	Time	Method
UPDRS Section III (ME) item (& total) scores.CGI Change from Baseline score.UPDRS Section II (ADL) item (& total) scores.CGI Severity of Illness score. H&Y Staging.All above at each visit and Endpoint (LOCF). Cogtest PD battery score each visit	24 weeks