Multiple System Atrophy of the Parkinsonian Subtype MedDRA version: 12.0 Level: PT Classification code 10064060 Term: Multiple system atrophy
Conditions
Interventions
Trade Name: AZILECT
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline
CAS Number: 161735-79-1
Current Sponsor code: TVP-1012
Other descriptive name: Rasagiline mesylate
Concentration unit: m
Sponsors
Teva Pharmaceutical Industries Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 a highly efficient method of birth control with a failure rate of less than 1%, when used consistently and correctly. [Highly efficient methods of birth control in this study include: surgical sterilization, contraceptive patch, hormonal intrauterine devices (hormone contraceptive coil), long-acting injectable contraceptive, hormone-releasing vaginal ring, hormone implant or partner's vasectomy.] In general, oral contraceptives also have a failure rate of less than 1%. In case of diarrhea or vomiting they are not considered to be highly efficient until the following menstruation. Methods of birth control which are not considered to be highly efficient: coil, intrauterine pessary, LEA contraceptive or condom, even in combination with spermicide (double barrier method). 10. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria, France, Germany, Hungary, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed