A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
NCT ID: NCT00515437
Last Updated: 2019-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2007-07-31
2008-09-30
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
DOUBLE
Study Groups
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1
1500U Myobloc
Botulinum Toxin Type B (Myobloc)
2
2500U Myobloc
Botulinum Toxin Type B (Myobloc)
3
3500U Myobloc
Botulinum Toxin Type B (Myobloc)
4
pooled placebo
Matched placebo to Myobloc
Interventions
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Botulinum Toxin Type B (Myobloc)
Matched placebo to Myobloc
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients previously exposed to botulinum toxins
* Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia
* Patients with prior salivary gland surgery
18 Years
85 Years
ALL
No
Sponsors
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Solstice Neurosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Pappert, MD
Role: STUDY_DIRECTOR
Solstice Neurosciences
Locations
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Dr Virgilio Evidente
Scottsdale, Arizona, United States
Dr. Ronald Ziman
Northridge, California, United States
Dr. James Sutton
Oxnard, California, United States
Dr. Olga Klepitskaya
Denver, Colorado, United States
Dr. Fernando Pagan
Washington D.C., District of Columbia, United States
Dr Hubert Fernandez
Gainesville, Florida, United States
Dr. Alan Freeman
Atlanta, Georgia, United States
Dr. Katie Kompoliti
Chicago, Illinois, United States
Dr. Robert Rodnitzky
Iowa City, Iowa, United States
Dr. Stephen Reich
Baltimore, Maryland, United States
Dr. Brad Racette
St Louis, Missouri, United States
Dr. Eric Molho
Albany, New York, United States
Dr. Joseph Friedman
Warwick, Rhode Island, United States
Dr. Vanessa Hinson
Charleston, South Carolina, United States
Dr. Sam Kabbani
Knoxville, Tennessee, United States
Dr. Madhavi Thomas
Dallas, Texas, United States
Dr. Gordon Smith
Salt Lake City, Utah, United States
Dr. Patrick Hogan
Tacoma, Washington, United States
Countries
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Other Identifiers
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SN-SIAL-201
Identifier Type: -
Identifier Source: org_study_id
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