A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

Conditions: Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0Level: PTClassification code 10064060Term: Multiple system atrophy

Registration Number: EUCTR2009-014644-11-PT

Lead Sponsor: Teva Pharmaceutical Industries Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

1.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).
2.Subjects who are less than 3 years from the time of documented MSA diagnosis.
3.Subjects with an anticipated survival of at least 3 years in the opinion of the investigator.
4.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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit.
2. Subjects with severe orthostatic symptoms as assessed by a score of = 3 on UMSARS question 9.
3. Subjects who meet any of the following criteria which tend to suggest advanced disease:
a.Speech impairment as assessed by a score of = 3 on UMSARS question 1
b.Swallowing impairment as assessed by a score of = 3 on UMSARS question 2
c.Impairment in ambulation as assessed by a score of = 3 on UMSARS question 7
d.Falling more frequently than once per week as assessed by a score of = 3 on UMSARS question 8
4. Subjects taking disallowed medications according to the locally approved Azilect® label.
5. Subjects taking MAO inhibitors within 3 months prior to baseline visit.
6. Subjects with hypertension whose blood pressure, in the investigator’s opinion, is not well controlled.
7. 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.
8. Subjects who have taken any investigational products within 60 days prior to baseline.
9. Women of child-bearing potential who do not practice an acceptable method of birth control.
10. Pregnant or nursing women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype. ;Secondary Objective: -;Primary end point(s): Change from baseline to Week 48/Termination visit in the total UMSARS score (the total UMSARS score is defined as the sum of Parts I + II)

Secondary Outcome Measures

Name	Time	Method

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