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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple System Atrophy

In brief

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

Key facts

Study ID

NCT00977665

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

174

Starts

2009-12-01

Expected to finish

2011-10-01

Last updated by the study team

2015-02-26

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 1004 — Irvine, California, United States
• Teva Investigational Site 1014 — La Jolla, California, United States
• Teva Investigational Site 1006 — Sunnyvale, California, United States
• Teva Investigational Site 1010 — Washington D.C., District of Columbia, United States
• Teva Investigational Site 1061 — Boca Raton, Florida, United States
• Teva Investigational Site 1012 — Tampa, Florida, United States
• Teva Investigational Site 1009 — Worcester, Massachusetts, United States
• Teva Investigational Site 1003 — Ann Arbor, Michigan, United States
• Teva Investigational Site 1007 — Rochester, Minnesota, United States
• Teva Investigational Site 1011 — St Louis, Missouri, United States
• Teva Investigational Site 1008 — Rochester, New York, United States
• Teva Investigational Site 1001 — Cleveland, Ohio, United States
• Teva Investigational Site 1002 — Philadelphia, Pennsylvania, United States
• Teva Investigational Site 1013 — Nashville, Tennessee, United States
• Teva Investigational Site 1005 — Houston, Texas, United States
• Teva Investigational Site 3305 — Graz, Austria
• Teva Investigational Site 3304 — Innsbruck, Austria
• Teva Investigational Site 1109 — Ottawa, Ontario, Canada
• Teva Investigational Site 1111 — Greenfield Park, Quebec, Canada
• Teva Investigational Site 1108 — Montreal, Quebec, Canada
• Teva Investigational Site 1110 — Québec, Quebec, Canada
• Teva Investigational Site 3503 — Lille, France
• Teva Investigational Site 3502 — Pessac, France
• Teva Investigational Site 3206 — Dresden, Germany
• Teva Investigational Site 3203 — Kiel, Germany

Full record on ClinicalTrials.gov

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