Overview

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.