Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations
Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations
Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either
 Rasagiline or Placebo
Inclusion Criteria:

 Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least
 two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without
 any other known or suspected cause of parkinsonism.

 Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours
 daily in the OFF state.

 Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide
 carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days
 prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not
 including a bedtime dose.

 Selegiline must be discontinued for at least 90 days prior to baseline.

 Subject must be age 30 or older.

 Subjects must be willing and able to give informed consent.

 Exclusion Criteria:

 Subjects with a clinically significant or unstable medical or surgical condition which
 would preclude safe and complete study participation. Such conditions may include
 cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as
 determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for
 Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)]
 within the 12 months preceding the Baseline visit.

 Subjects who have undergone neurosurgical transplantation are excluded regardless of when
 the procedure(s) was performed. No programming changes are permitted in subjects who have
 undergone DBS.

 Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO
 inhibitors, reserpine, methyldopa within the past three months, or treatment with an
 anti-emetic or neuroleptic medication with central dopamine antagonist activity with the
 past six months.