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)
NCT ID: NCT00977665
Last Updated: 2015-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
174 participants
INTERVENTIONAL
2009-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rasagiline mesylate
rasagiline tablet, 1 mg/day for up to 48 weeks.
rasagiline mesylate
rasagiline 1 mg tablet/day for 48 weeks
placebo
placebo tablet for up to 48 weeks.
placebo
placebo tablet for 48 weeks
Interventions
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rasagiline mesylate
rasagiline 1 mg tablet/day for 48 weeks
placebo
placebo tablet for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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:
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 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.
30 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Werner Poewe, Prof
Role: PRINCIPAL_INVESTIGATOR
Innsbruck Medical University, Innsbruck, Austria
Locations
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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
Teva Investigational Site 3201
Marburg, , Germany
Teva Investigational Site 3205
München, , Germany
Teva Investigational Site 3204
Tübingen, , Germany
Teva Investigational Site 3202
Ulm, , Germany
Teva Investigational Site 5101
Budapest, , Hungary
Teva Investigational Site 5102
Debrecen, , Hungary
Teva Investigational Site 5103
Miskolc, , Hungary
Teva Investigational Site 8002
Ramat Gan, IL, Israel
Teva Investigational Site 8004
Haifa, , Israel
Teva Investigational Site 8003
Tel Aviv, , Israel
Teva Investigational Site 3006
Bologna, , Italy
Teva Investigational Site 3004
Roma, , Italy
Teva Investigational Site 3005
Venezia - Lido, , Italy
Teva Investigational Site 3801
Amersfoort, , Netherlands
Teva Investigational Site 3802
Sittard-Geleen, , Netherlands
Teva Investigational Site 3603
Lisbon, , Portugal
Teva Investigational Site 3101
Barcelona, , Spain
Teva Investigational Site 3102
Barcelona, , Spain
Teva Investigational Site 3103
Seville, , Spain
Teva Investigational Site 3403
Cardiff, Wales, , United Kingdom
Teva Investigational Site 3401
London, , United Kingdom
Teva Investigational Site 3402
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8.
Other Identifiers
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2009-014644-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MSA-RAS-202
Identifier Type: -
Identifier Source: org_study_id
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