Status:
COMPLETED
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)
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
Eligibility Criteria
Inclusion
- 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
- 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:
- Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
- Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
- Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00977665
Start Date
December 1 2009
End Date
October 1 2011
Last Update
February 26 2015
Active Locations (47)
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1
Teva Investigational Site 1004
Irvine, California, United States
2
Teva Investigational Site 1014
La Jolla, California, United States
3
Teva Investigational Site 1006
Sunnyvale, California, United States
4
Teva Investigational Site 1010
Washington D.C., District of Columbia, United States