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) - ND
- Conditions
- Multiple System Atrophy of the Parkinsonian subtype (MSA-P)MedDRA version: 12.1Level: LLTClassification code 10064060Term: Multiple system atrophy
- Registration Number
- EUCTR2009-014644-11-IT
- Lead Sponsor
- Teva Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
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.
Imaging Substudy inclusion criteria All subjects from sites participating in the substudy who are willing and able to give informed consent for this substudy. 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
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 [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)]. 10.Pregnant or nursing women.
Imaging Substudy exclusion criteria Any condition which would make the subject, in the opinion of the investigator, unsuitable for an MRI study (e.g. pacemakers; medical or bio-stimulation implants which are contraindicated for MRI scans and which may include vagus nerve stimulators, implantable cardioverter-defibrillators, loop recorders, insulin pumps, cochlear implants).
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: None;Primary end point(s): Primary efficacy endpoint: 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