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)

• Register: EUCTR
• Last refreshed on: 22 October 2012
• Main ID: EUCTR2009-014644-11-DE
• Date of registration: 15/09/2009
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries Ltd
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 08/12/2009
• Target sample size: 140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014644-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, France, Germany, Hungary, Italy, Netherlands, Portugal, Spain, United Kingdom

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 Objective: -

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

Secondary ID(s)

MSA-RAS-202