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)

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00977665
First received: September 15, 2009
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Multiple System Atrophy
Drug: rasagiline mesylate
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change from baseline to Week 48/Termination visit in the total UMSARS score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to week 24 in total UMSARS score. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Ambulation endpoint: whether or not a subject achieves a score of > 3 in UMSARS question 7 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The score of the COMPASS Select Change scale at Week 48/Termination visit assessed with respect to baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 48/Termination visit in the MSA-QoL scale [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: November 2009
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rasagiline mesylate
rasagiline 1 mg/day
Drug: rasagiline mesylate
randomized 1:1 ratio either rasagiline 1 mg tablet/day or matching placebo for 48 weeks
Other Name: Azilect
Placebo Comparator: placebo
placebo
Other: placebo
placebo
Other Name: placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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 UMSARS question 9.
  • Subjects who meet any of the following criteria which tend to suggest advanced disease:

    1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
    2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
    3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
    4. 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977665

  Hide Study Locations
Locations
United States, California
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
United States, District of Columbia
Teva Investigational Site 1010
Washington, District of Columbia, United States
United States, Florida
Teva Investigational Site 1061
Boca Raton, Florida, United States
Teva Investigational Site 1012
Tampa, Florida, United States
United States, Massachusetts
Teva Investigational Site 1009
Worcester, Massachusetts, United States
United States, Michigan
Teva Investigational Site 1003
Ann Arbor, Michigan, United States
United States, Minnesota
Teva Investigational Site 1007
Rochester, Minnesota, United States
United States, Missouri
Teva Investigational Site 1011
St. Louis, Missouri, United States
United States, New York
Teva Investigational Site 1008
Rochester, New York, United States
United States, Ohio
Teva Investigational Site 1001
Cleveland, Ohio, United States
United States, Pennsylvania
Teva Investigational Site 1002
Philadelphia, Pennsylvania, United States
United States, Tennessee
Teva Investigational Site 1013
Nashville, Tennessee, United States
United States, Texas
Teva Investigational Site 1005
Houston, Texas, United States
Austria
Teva Investigational Site 3305
Graz, Austria
Teva Investigational Site 3304
Innsbruck, Austria
Canada, Ontario
Teva Investigational Site 1109
Ottawa, Ontario, Canada
Canada, Quebec
Teva Investigational Site 1111
Greenfield Park, Quebec, Canada
Teva Investigational Site 1108
Montréal, Quebec, Canada
Teva Investigational Site 1110
Québec, Quebec, Canada
France
Teva Investigational Site 3503
Lille Cedex, France
Teva Investigational Site 3502
Pessac, France
Germany
Teva Investigational Site 3206
Dresden, Germany
Teva Investigational Site 3203
Kiel, Germany
Teva Investigational Site 3201
Marburg, Germany
Teva Investigational Site 3205
Muenchen, Germany
Teva Investigational Site 3204
Tuebingen, Germany
Teva Investigational Site 3202
Ulm, Germany
Hungary
Teva Investigational Site 5101
Budapest, Hungary
Teva Investigational Site 5102
Debrecen, Hungary
Teva Investigational Site 5103
Miskolc, Hungary
Israel
Teva Investigational Site 8002
Ramat -Gan, IL, Israel
Teva Investigational Site 8004
Haifa, Israel
Teva Investigational Site 8003
Tel Aviv, Israel
Italy
Teva Investigational Site 3006
Bologna, Italy
Teva Investigational Site 3004
Roma, Italy
Teva Investigational Site 3005
Venezia - Lido, Italy
Netherlands
Teva Investigational Site 3801
Amersfoort, Netherlands
Teva Investigational Site 3802
Sittard-Geleen, Netherlands
Portugal
Teva Investigational Site 3603
Lisbon, Portugal
Spain
Teva Investigational Site 3101
Barcelona, Spain
Teva Investigational Site 3102
Barcelona, Spain
Teva Investigational Site 3103
Sevilla, Spain
United Kingdom
Teva Investigational Site 3403
Cardiff, Wales, United Kingdom
Teva Investigational Site 3401
London, United Kingdom
Teva Investigational Site 3402
Newcastle-Upon-Tyne, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
H. Lundbeck A/S
Investigators
Principal Investigator: Werner Poewe, Prof Innsbruck Medical University, Innsbruck, Austria
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00977665     History of Changes
Other Study ID Numbers: MSA-RAS-202, EudraCT Number:2009-014644-11
Study First Received: September 15, 2009
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014