Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

Exclusion Criteria

• •Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit.
• •Subjects with severe orthostatic symptoms as assessed by a score of ≥ 3 on Unified Multiple System Atrophy Rating Scale (UMSARS) question 9.
• •Subjects who meet any of the following criteria which tend to suggest advanced disease:
• •1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
• •2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
• •3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
• •4. Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8
• •Subjects taking disallowed medications according to the locally approved Azilect® label.
• •Subjects taking monoamine oxidase (MAO) inhibitors within 3 months prior to baseline visit.
• •Subjects with hypertension whose blood pressure, in the investigator's opinion, is not well controlled.
• •Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Subjects with moderate or severe hepatic impairment.
• •Subjects who have taken any investigational products within 60 days prior to baseline.
• •Women of child-bearing potential who do not practice an acceptable method of birth control \[acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide)\].
• •Pregnant or nursing women.