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A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

CompletedPhase 2

Sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Conditions: Drooling

Interventions: Botulinum Toxin Type B (Myobloc), Matched placebo to Myobloc

Countries: United States

To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Parkinsons' Disease patients with Sialorrhea for at least 3 months

Exclusion Criteria:

* Patients with non-idiopathic PD parkinsonism
* 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

Locations (18)

Scottsdale, Arizona, United States
Northridge, California, United States
Oxnard, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Albany, New York, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Tacoma, Washington, United States