Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
NCT ID: NCT01994109
Last Updated: 2021-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
187 participants
INTERVENTIONAL
2013-11-30
2017-01-31
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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MYOBLOC 2500 U
Subjects will receive specified dose of MYOBLOC
MYOBLOC
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
MYOBLOC 3500 U
Subjects will receive specified dose of MYOBLOC
MYOBLOC
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Placebo
Subjects will receive volume matched Placebo
PLACEBO
Interventions
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MYOBLOC
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
PLACEBO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior botulinum toxin treatment to the salivary glands at any time
18 Years
85 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Najeebah Abdul-Musawir, MD,MBA
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
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Loma Linda, California, United States
Los Angeles, California, United States
National City, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Port Charlotte, Florida, United States
Carmel, Indiana, United States
Baltimore, Maryland, United States
Elkridge, Maryland, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Edison, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Port Royal, South Carolina, United States
Cordova, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Kirkland, Washington, United States
Tacoma, Washington, United States
Irkutsk, Irkutsk Oblast, Russia
Vsevolozhsk, Leningradskaya Oblast', Russia
Saint Petersburg, Petrodvorets, Russia
Krasnoyarsk, , Russia
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Lviv, , Ukraine
Rivne, , Ukraine
Uzhhorod, , Ukraine
Countries
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References
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Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial. Mov Disord. 2012 Feb;27(2):219-26. doi: 10.1002/mds.23929. Epub 2011 Sep 1.
Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004 Jan 13;62(1):37-40. doi: 10.1212/01.wnl.0000101713.81253.4c.
Isaacson SH, Ondo W, Jackson CE, Trosch RM, Molho E, Pagan F, Lew M, Dashtipour K, Clinch T, Espay AJ; MYSTICOL Study Group. Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial. JAMA Neurol. 2020 Apr 1;77(4):461-469. doi: 10.1001/jamaneurol.2019.4565.
Other Identifiers
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SN-SIAL-301
Identifier Type: -
Identifier Source: org_study_id
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