A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
1 other identifier
interventional
54
1 country
18
Brief Summary
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
August 13, 2009
CompletedApril 21, 2026
March 1, 2026
11 months
August 10, 2007
May 12, 2009
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
9 point scale, 0 = no drooling, 9 = severe drooling
baseline versus 4 weeks post-injection
Secondary Outcomes (3)
Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
baseline vs 12 weeks post injection
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
baseline vs 4 weeks post-injection
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
baseline vs 12 weeks post-injection
Study Arms (4)
Treatment 1
EXPERIMENTAL1,500 Units (0.3 mL) MYOBLOC (0.3mL) with 500 Units (0.1 mL) injected into each parotid gland and 250 Units (0.05 mL) inject into each submandibular gland and will be compared to pooled placebo
Treatment 2
EXPERIMENTAL2,500 Units of (0.5mL) MYOBLOC with 1,000 Units (0.2 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo
Treatment 3
EXPERIMENTAL3,500 Units of (0.7mL) MYOBLOC with 1,500 Units (0.3 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo
Treatment 4
PLACEBO COMPARATORvolume-matched placebo injected into each parotid gland and each submandibular gland
Interventions
Eligibility Criteria
You may qualify if:
- Parkinsons' Disease patients with Sialorrhea for at least 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Dr Virgilio Evidente
Scottsdale, Arizona, 85259, United States
Dr. Ronald Ziman
Northridge, California, 91325, United States
Dr. James Sutton
Oxnard, California, 93030, United States
Dr. Olga Klepitskaya
Denver, Colorado, 80262, United States
Dr. Fernando Pagan
Washington D.C., District of Columbia, 20007, United States
Dr Hubert Fernandez
Gainesville, Florida, 32610, United States
Dr. Alan Freeman
Atlanta, Georgia, 30329, United States
Dr. Katie Kompoliti
Chicago, Illinois, 60612, United States
Dr. Robert Rodnitzky
Iowa City, Iowa, 52242, United States
Dr. Stephen Reich
Baltimore, Maryland, 21201, United States
Dr. Brad Racette
St Louis, Missouri, 63110, United States
Dr. Eric Molho
Albany, New York, 12205, United States
Dr. Joseph Friedman
Warwick, Rhode Island, 02886, United States
Dr. Vanessa Hinson
Charleston, South Carolina, 29401, United States
Dr. Sam Kabbani
Knoxville, Tennessee, 37923, United States
Dr. Madhavi Thomas
Dallas, Texas, 75231, United States
Dr. Gordon Smith
Salt Lake City, Utah, 84132, United States
Dr. Patrick Hogan
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Regulatory Affairs Specialist
- Organization
- Solstice Neurosciences, Inc
Study Officials
- STUDY DIRECTOR
Jonathan Rubin, MD,MBA
Supernus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2007
First Posted
August 13, 2007
Study Start
July 1, 2007
Primary Completion
June 1, 2008
Study Completion
September 1, 2008
Last Updated
April 21, 2026
Results First Posted
August 13, 2009
Record last verified: 2026-03