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)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Collaborator: H. Lundbeck A/S
• Treatments: Rasagiline

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.