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

Newron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: Safinamide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643045

NW 1015/015/III/2003

Details and patient eligibility

About

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.

Enrollment: 269 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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269 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Low dose (50-100mg/day)

Treatment:

Drug: Safinamide

Drug: Safinamide

2

Experimental group

Description:

High dose (150-200 mg/day)

Treatment:

Drug: Safinamide

Drug: Safinamide

3

Placebo Comparator group

Treatment:

Drug: Placebo