CompletedNCT00515437Updated Apr 21, 2026Results posted

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

A Phase 2 interventional study of Botulinum Toxin Type B (Myobloc) and Matched placebo to Myobloc in Drooling, sponsored by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC. Completed at 18 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 54
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Drooling

Browse trials for

Sialorrhea 60

Keywords

Sialorrhea

In context

Sialorrhea

60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.

This study's enrollment of 54 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Parkinsons' Disease patients with Sialorrhea for at least 3 months

Exclusion criteria

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 54 participants (actual)

Study arms

Experimental
Treatment 1
1,500 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
Biological: Botulinum Toxin Type B (Myobloc)
Experimental
Treatment 2
2,500 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
Biological: Botulinum Toxin Type B (Myobloc)
Experimental
Treatment 3
3,500 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
Biological: Botulinum Toxin Type B (Myobloc)
Placebo comparator
Treatment 4
volume-matched placebo injected into each parotid gland and each submandibular gland
Biological: Matched placebo to Myobloc

Interventions

BiologicalBotulinum Toxin Type B (Myobloc)
BiologicalMatched placebo to Myobloc

What researchers measure

Primary outcomes

Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
9 point scale, 0 = no drooling, 9 = severe drooling
Time frame: baseline versus 4 weeks post-injection

Secondary outcomes

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
9 point scale (0=no drooling, 9=severe drooling)
Time frame: baseline vs 12 weeks post injection
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"
Time frame: baseline vs 4 weeks post-injection
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
saliva collected over 5 minutes and weighed to produce a grams/minute "rate"
Time frame: baseline vs 12 weeks post-injection

Results

Posted Aug 13, 2009

Participant flow

24 centers were initiated to screen and enroll subjects. Enrollment began in July 2007 and completed in March 2008. 54 subjects were enrolled at 17 centers

Participant flow — Overall Study
Milestone	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Started	14	12	13	15
Completed	14	12	13	14
Not completed	0	0	0	1

Outcome measures

PrimaryChange in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection

9 point scale, 0 = no drooling, 9 = severe drooling

Time frame:: baseline versus 4 weeks post-injection
Reported as:: Mean · points on a scale

Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
points on a scale	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection	-2.1 ± 1.2	-3.3 ± 1.4	-3.5 ± 1.0	-1.3 ± 1.3

SecondaryChange in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection

9 point scale (0=no drooling, 9=severe drooling)

Time frame:: baseline vs 12 weeks post injection
Reported as:: Mean · points on a scale

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
points on a scale	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection	-1.9 ± 1.5	-2.2 ± 1.6	-2.2 ± 0.8	-1.2 ± 1.3

SecondaryChange in Unstimulated Salivary Flow Rate at Wk 4 Post-injection

saliva is collected over 5 minutes and weighed to produce a grams/minute "rate"

Time frame:: baseline vs 4 weeks post-injection
Reported as:: Mean · grams/minute

Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
grams/minute	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection	-0.497 ± 0.38	-.381 ± 0.34	-0.146 ± 0.14	-0.052 ± 0.33

SecondaryChange in Unstimulated Salivary Flow Rate at Wk 12 Post-injection

saliva collected over 5 minutes and weighed to produce a grams/minute "rate"

Time frame:: baseline vs 12 weeks post-injection
Reported as:: Mean · grams/minute

Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
grams/minute	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection	-0.414 ± 0.37	-0.166 ± 0.31	-0.028 ± 0.21	0.108 ± 0.35

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1500U Myobloc	—	—	—
2500U Myobloc	—	—	—
3500U Myobloc	—	—	—
Placebo	—	—	—

Most frequent serious events

Most frequent serious events
Event	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Rectal HemmorhageGastrointestinal disorders	0/14	1/12	0/13	0/15
Atrial FibrillationCardiac disorders	0/14	0/12	1/13	0/15
UrosepsisInfections and infestations	0/14	0/12	1/13	0/15
Cardiac Failure CongestiveCardiac disorders	0/14	0/12	0/13	1/15
DyspneaRespiratory, thoracic and mediastinal disorders	0/14	0/12	0/13	1/15
PneumonitisRespiratory, thoracic and mediastinal disorders	0/14	0/12	0/13	1/15

Most frequent other events

Most frequent other events
Event	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo
Dry MouthGastrointestinal disorders	1/14	2/12	1/13	0/15
Breath OdorGastrointestinal disorders	1/14	2/12	1/13	0/15
Musculoskeletal StiffnessMusculoskeletal and connective tissue disorders	0/14	1/12	0/13	0/15
DysgeusiaNervous system disorders	0/14	0/12	1/13	0/15
Saliva AlteredGastrointestinal disorders	1/14	0/12	0/13	0/15
Tongue CoatedGastrointestinal disorders	1/14	0/12	0/13	0/15
TrismusMusculoskeletal and connective tissue disorders	1/14	0/12	0/13	0/15
ChokingRespiratory, thoracic and mediastinal disorders	0/14	0/12	0/13	1/15

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	5	2	0	3	10
>=65 years	9	10	13	12	44

Age, Continuous
Age, Continuous(years)	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo	Total
Mean	67 ± 7	71 ± 8	74 ± 5	71 ± 11	71 ± 8

Sex: Female, Male
Sex: Female, Male(Participants)	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo	Total
Female	2	0	2	2	6
Male	12	12	11	13	48

Region of Enrollment
Region of Enrollment(participants)	1500U Myobloc	2500U Myobloc	3500U Myobloc	Placebo	Total
United States	14	12	13	15	54

Study locations

18 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00515437
Lead sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
Responsible party: Sponsor
First posted: Aug 13, 2007
Start date: Jul 2007
Primary completion: Jun 2008
Completion: Sep 2008
Results posted: Aug 13, 2009
Last update: Apr 21, 2026

Study contacts

Jonathan Rubin, MD,MBA

study director · Supernus Pharmaceuticals, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: rimabotulinumtoxinB

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

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