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New drooling treatment shows promise in Year-Long study

NCT ID NCT02610868

Symptom relief Sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of repeated MYOBLOC injections over one year in 187 adults with troublesome drooling caused by conditions like Parkinson's disease, stroke, or ALS. Participants received up to four treatment sessions, and researchers tracked side effects and changes in saliva flow. The goal was to see if this botulinum toxin treatment could safely reduce drooling over the long term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

187 people

The number who actually took part.

Start date

Oct 2015

Finished

Jun 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. * Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent. * Male or female, 18 to 85 years of age (inclusive). * Minimum unstimulated salivary flow rate of 0.2 g/min at screening * Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. * Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis Exclusion Criteria: * A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. * Respiratory forced vital capacity (FVC) of \<20% of predicted * Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening * Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete). * Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function * Prior salivary gland surgery * Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary * Evidence of any clinically significant neurologic disease * Pregnancy or lactation * Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. * Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. * Current infection at the sialorrhea treatment injection site(s) * History of drug or alcohol abuse currently or within the previous 6 months * Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study

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Conditions

The condition(s) this trial relates to.

cerebral palsy Sialorrhea stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sialorrhea

Contacts and locations

Locations

  • Study site

    Phoenix, Arizona, 85013, United States

  • Study site

    Scottsdale, Arizona, 85258, United States

  • Study site

    Scottsdale, Arizona, 85259, United States

  • Study site

    Loma Linda, California, 92354, United States

  • Study site

    Los Angeles, California, 90033, United States

  • Study site

    Aurora, Colorado, 80045, United States

  • Study site

    Atlantis, Florida, 33462, United States

  • Study site

    Boca Raton, Florida, 33486, United States

  • Study site

    Orlando, Florida, 32806, United States

  • Study site

    Port Charlotte, Florida, 33980, United States

  • Study site

    Atlanta, Georgia, 30329, United States

  • Study site

    Kansas City, Kansas, 66160, United States

  • Study site

    Overland Park, Kansas, 66211, United States

  • Study site

    Elkridge, Maryland, 21075, United States

  • Study site

    Farmington Hills, Michigan, 48334, United States

  • Study site

    St Louis, Missouri, 63110, United States

  • Study site

    Las Vegas, Nevada, 89145, United States

  • Study site

    Edison, New Jersey, 08818, United States

  • Study site

    Centerville, Ohio, 45459, United States

  • Study site

    Tulsa, Oklahoma, 74136, United States

  • Study site

    Greenville, South Carolina, 29615, United States

  • Study site

    Cordova, Tennessee, 38018, United States

  • Study site

    San Antonio, Texas, 78229, United States

  • Study site

    Kirkland, Washington, 98034, United States

  • Study site

    Spokane, Washington, 99202, United States

  • Study site

    Tacoma, Washington, 98409, United States

  • Study site

    Grodno, 230017, Belarus

  • Study site

    Dnipropetrovsk, 49027, Ukraine

  • Study site

    Ivano-Frankivsk, 76008, Ukraine

  • Study site

    Kharkiv, 61068, Ukraine

  • Study site

    Lviv, 79010, Ukraine

  • Study site

    Odesa, 65025, Ukraine

  • Study site

    Rivne, 33010, Ukraine

  • Study site

    Uzhhorod, 88018, Ukraine

  • Study site

    Zaporizhzhya, 69600, Ukraine

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