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)
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: rasagiline mesylate; placebo
Intervention description: rasagiline 1 mg tablet/day for 48 weeks; placebo tablet for 48 weeks
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the
             parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008).

          -  Subjects who are less than 3 years from the time of documented MSA diagnosis.

          -  Subjects with an anticipated survival of at least 3 years in the opinion of the
             investigator.

          -  Subjects who are willing and able to give informed consent. Subjects who are not able
             to write may give verbal consent in the presence of at least one witness, and the
             witness should sign the informed consent form.

        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.