Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

Inclusion Criteria:

Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's
Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off"
phase.

Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for
at least 4 weeks.

Have motor fluctuations, with >1.5 hours "off" time during the day. Be able to maintain an
accurate and complete diary (18-hour)

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;.

Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or
biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.

Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3
months.

Have received treatment with safinamide previously. History of, or current depression
psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive
dysfunction. History of allergic response to anticonvulsants, levodopa, or other
anti-Parkinsonian agents.

Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including
any of the following conditions: albino subjects, family history of hereditary retinal
disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis
pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular
inflammation (uveitis), or diabetic retinopathy.