A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
- Conditions
- Drooling
- Interventions
- Biological: Botulinum Toxin Type B (Myobloc)Biological: Matched placebo to Myobloc
- Registration Number
- NCT00515437
- Lead Sponsor
- Solstice Neurosciences
- Brief Summary
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
- Detailed Description
This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Parkinsons' Disease patients with Sialorrhea for at least 3 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Botulinum Toxin Type B (Myobloc) 3500U Myobloc 2 Botulinum Toxin Type B (Myobloc) 2500U Myobloc 1 Botulinum Toxin Type B (Myobloc) 1500U Myobloc 4 Matched placebo to Myobloc pooled placebo
- Primary Outcome Measures
Name Time Method Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection baseline versus 4 weeks post-injection 9 point scale, 0 = no drooling, 9 = severe drooling
- Secondary Outcome Measures
Name Time Method Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection baseline vs 12 weeks post injection 9 point scale (0=no drooling, 9=severe drooling)
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection baseline vs 12 weeks post-injection saliva collected over 5 minutes and weighed to produce a grams/minute "rate"
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection baseline vs 4 weeks post-injection saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
Trial Locations
- Locations (18)
Dr. Madhavi Thomas
🇺🇸Dallas, Texas, United States
Dr. Stephen Reich
🇺🇸Baltimore, Maryland, United States
Dr. James Sutton
🇺🇸Oxnard, California, United States
Dr. Eric Molho
🇺🇸Albany, New York, United States
Dr. Fernando Pagan
🇺🇸Washington, District of Columbia, United States
Dr. Brad Racette
🇺🇸Saint Louis, Missouri, United States
Dr. Joseph Friedman
🇺🇸Warwick, Rhode Island, United States
Dr. Gordon Smith
🇺🇸Salt Lake City, Utah, United States
Dr. Katie Kompoliti
🇺🇸Chicago, Illinois, United States
Dr. Olga Klepitskaya
🇺🇸Denver, Colorado, United States
Dr Hubert Fernandez
🇺🇸Gainesville, Florida, United States
Dr. Alan Freeman
🇺🇸Atlanta, Georgia, United States
Dr Virgilio Evidente
🇺🇸Scottsdale, Arizona, United States
Dr. Ronald Ziman
🇺🇸Northridge, California, United States
Dr. Vanessa Hinson
🇺🇸Charleston, South Carolina, United States
Dr. Patrick Hogan
🇺🇸Tacoma, Washington, United States
Dr. Robert Rodnitzky
🇺🇸Iowa City, Iowa, United States
Dr. Sam Kabbani
🇺🇸Knoxville, Tennessee, United States