DroolingPhase 2NCT00515437

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

A Phase 2 study testing Botulinum Toxin Type B (Myobloc) in people with Drooling, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Drooling
What is being tested?: Botulinum Toxin Type B (Myobloc)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 18 sitesUnited States
Study dates: Jul 2007to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Parkinsons' Disease patients with Sialorrhea for at least 3 months

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Dr. Eric Molho
Albany, New York, 12205
Dr. Alan Freeman
Atlanta, Georgia, 30329
Dr. Stephen Reich
Baltimore, Maryland, 21201
Dr. Vanessa Hinson
Charleston, South Carolina, 29401
Dr. Katie Kompoliti
Chicago, Illinois, 60612
Dr. Madhavi Thomas
Dallas, Texas, 75231
Dr. Olga Klepitskaya
Denver, Colorado, 80262
Dr Hubert Fernandez
Gainesville, Florida, 32610
Dr. Robert Rodnitzky
Iowa City, Iowa, 52242
Dr. Sam Kabbani
Knoxville, Tennessee, 37923
Dr. Ronald Ziman
Northridge, California, 91325
Dr. James Sutton
Oxnard, California, 93030
Dr. Gordon Smith
Salt Lake City, Utah, 84132
Dr Virgilio Evidente
Scottsdale, Arizona, 85259
Dr. Brad Racette
St Louis, Missouri, 63110
Dr. Patrick Hogan
Tacoma, Washington, 98405
Dr. Joseph Friedman
Warwick, Rhode Island, 02886
Dr. Fernando Pagan
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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

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: Drooling
Being tested: Botulinum Toxin Type B (Myobloc), Matched placebo to Myobloc
Keywords: Sialorrhea
Medical subject headings: Sialorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type B (Myobloc)Biological
Matched placebo to MyoblocBiological

Study groups in NCT00515437
Study group	Role	What they receive
Treatment 1	Experimental	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 Receives: Biological: Botulinum Toxin Type B (Myobloc)
Treatment 2	Experimental	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 Receives: Biological: Botulinum Toxin Type B (Myobloc)
Treatment 3	Experimental	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 Receives: Biological: Botulinum Toxin Type B (Myobloc)
Treatment 4	Placebo comparator	volume-matched placebo injected into each parotid gland and each submandibular gland Receives: Biological: Matched placebo to Myobloc

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
9 point scale (0=no drooling, 9=severe drooling)
Measured: 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"
Measured: 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"
Measured: baseline vs 12 weeks post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Sep 2008

First posted13 Aug 2007 (estimated)
Study startJul 2007
Primary completionJun 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DroolingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00515437
Sponsor's protocol ID: SN-SIAL-201
Status last verified: Mar 2026
First submitted: 10 Aug 2007
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Efficacy of Targeted Pelvic Floor Muscle Exercises for Treatment of Men With Primary Post Micturition Dribbling: a Randomized Controlled Trial.
Post Micturition Dribble
Not yet recruiting
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Cerebral Palsy (CP), Drooling
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)
Not yet recruiting
Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation
Hypersialorrhea (Excessive Salivation), Psychiatric Disorders

All Drooling trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00515437
Acronym / sponsor ID: SN-SIAL-201
Conditions: Drooling
Keywords: Sialorrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jun 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 13 Aug 2007 (estimated)
Results: Posted 13 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

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

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Parkinsons' Disease patients with Sialorrhea for at least 3 months

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum Toxin Type B (Myobloc)	Biological	Treatment 1, Treatment 2, Treatment 3
Matched placebo to Myobloc	Biological	Treatment 4

Primary outcome

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

3 secondary outcomes

Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection
Time frame: baseline vs 12 weeks post injection
Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection
Time frame: baseline vs 4 weeks post-injection
Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection
Time frame: baseline vs 12 weeks post-injection

Results and safety

Results posted to the registry on 13 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1500U Myobloc	14	14
2500U Myobloc	12	12
3500U Myobloc	13	13
Placebo	15	14

Primary outcome: Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection

Time frame: baseline versus 4 weeks post-injection. Mean (Standard Deviation). Unit: points on a scale

Measure	1500U Myobloc n = 14	2500U Myobloc n = 12	3500U Myobloc n = 13	Placebo n = 14
Value	-2.1 (1.2)	-3.3 (1.4)	-3.5 (1.0)	-1.3 (1.3)

Population analysed: Intent to Treat (ITT)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1500U Myobloc	0 of ?	2 of ?	Not reported
2500U Myobloc	1 of ?	3 of ?	Not reported
3500U Myobloc	1 of ?	2 of ?	Not reported
Placebo	3 of ?	1 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Drooling

Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Efficacy of Targeted Pelvic Floor Muscle Exercises for Treatment of Men With Primary Post Micturition Dribbling: a Randomized Controlled Trial.
Post Micturition Dribble
Not yet recruiting
Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Cerebral Palsy (CP), Drooling
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)
Not yet recruiting
Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation
Hypersialorrhea (Excessive Salivation), Psychiatric Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Rubin, MD,MBA study director

Supernus Pharmaceuticals, Inc.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum Toxin Type B (Myobloc) in people with Drooling, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection (time frame: baseline versus 4 weeks post-injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00515437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.