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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newron; Newron Pharmaceuticals SPA
• Treatments: Dopamine; Dopamine Agonists

Criteria

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.