A Phase 3 interventional study of MYOBLOC and PLACEBO in Sialorrhea, sponsored by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC. Completed at 34 sites in 3 countries. 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 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.
Primary Objective: To determine the efficacy of MYOBLOC (administered via intraglandular as a single total dose of 2,500 Units or 3,500 Units) versus placebo in the treatment of troublesome sialorrhea in adult subjects via the assessment of unstimulated salivary flow rate and clinical global impression of sialorrhea severity and improvement at Week 4 post-injection (Part A). It is hypothesized that both MYOBLOC doses will achieve greater efficacy than placebo in relieving sialorrhea at 4 weeks post-injection.
To compare the safety and tolerability of MYOBLOC versus placebo over a 13 week post-injection period (Part A).
Secondary Objective: To assess the onset and duration of therapeutic response of MYOBLOC using efficacy assessments performed at Weeks 1, 2, 4, 8, and 13 after the first treatment (Part A).
To assess the duration of therapeutic response of MYOBLOC (administered via intraglandular as a single total dose of 3,500 Units) using efficacy assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
To determine the long-term safety and tolerability of MYOBLOC treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 187 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →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.
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Exclusion Criteria:
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
Subjects will receive volume matched Placebo
Other: PLACEBO
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Also known as: rimabotulinumtoxinB, botulinum toxin type B
Also known as: volume-matched placebo
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
Change weight of expectorated saliva at a Week 4 post-injection visit.
Time frame: 4 Weeks
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
Time frame: 4 weeks
The study was conducted at 33 sites including United States, Russia and Ukraine.
| Milestone | DB: MYOBLOC 2500 U | DB: MYOBLOC 3500 U | DB: Placebo | OL: ALL MYOBLOC |
|---|---|---|---|---|
| Started | 63 | 64 | 60 | 0 |
| Completed | 62 | 61 | 53 | 0 |
| Not completed | 1 | 3 | 7 | 0 |
| Milestone | DB: MYOBLOC 2500 U | DB: MYOBLOC 3500 U | DB: Placebo | OL: ALL MYOBLOC |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 170 |
| Completed | 0 | 0 | 0 | 128 |
| Not completed | 0 | 0 | 0 | 42 |
Change weight of expectorated saliva at a Week 4 post-injection visit.
| g/minute | MYOBLOC 2500 U | MYOBLOC 3500 U | Placebo |
|---|---|---|---|
| Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | -0.37 ± 0.03 | -0.36 ± 0.03 | -0.07 ± 0.03 |
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
| score on a scale | MYOBLOC 2500 U | MYOBLOC 3500 U | Placebo |
|---|---|---|---|
| Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | 2.38 ± 0.12 | 2.45 ± 0.12 | 3.59 ± 0.13 |
Collected over Part A: 13-Week Post-Injection Period; Part B: 4 Sessions of 13-Week (+/- 2 Weeks) Post-Injection Periods. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MYOBLOC 2500 U (Part A) | 0/63 (0%) | 1/63 (1.6%) | 44/63 (69.8%) |
| MYOBLOC 3500 U (Part A) | 2/64 (3.1%) | 4/64 (6.3%) | 38/64 (59.4%) |
| Placebo (Part A) | 1/60 (1.7%) | 4/60 (6.7%) | 16/60 (26.7%) |
| OL: ALL MYOBLOC (Part B) | 9/170 (5.3%) | 32/170 (18.8%) | 143/170 (84.1%) |
| Event | MYOBLOC 2500 U (Part A) | MYOBLOC 3500 U (Part A) | Placebo (Part A) | OL: ALL MYOBLOC (Part B) |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/63 | 1/64 | 0/60 | 5/170 |
| Urinary tract infectionInfections and infestations | 1/63 | 0/64 | 0/60 | 3/170 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/63 | 0/64 | 0/60 | 3/170 |
| Small intestinal obstructionGastrointestinal disorders | 0/63 | 0/64 | 1/60 | 0/170 |
| UrosepsisInfections and infestations | 0/63 | 0/64 | 1/60 | 0/170 |
| Nodular melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/63 | 0/64 | 1/60 | 0/170 |
| Circulatory collapseVascular disorders | 0/63 | 0/64 | 1/60 | 0/170 |
| Cardio-respiratory arrestCardiac disorders | 0/63 | 1/64 | 0/60 | 2/170 |
| MalaiseGeneral disorders | 0/63 | 1/64 | 0/60 | 1/170 |
| Brain cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/63 | 1/64 | 0/60 | 0/170 |
| Event | MYOBLOC 2500 U (Part A) | MYOBLOC 3500 U (Part A) | Placebo (Part A) | OL: ALL MYOBLOC (Part B) |
|---|---|---|---|---|
| Dry mouthGastrointestinal disorders | 24/63 | 29/64 | 5/60 | 73/170 |
| Dental cariesGastrointestinal disorders | 5/63 | 3/64 | 2/60 | 50/170 |
| FallInjury, poisoning and procedural complications | 4/63 | 3/64 | 4/60 | 28/170 |
| DysphagiaGastrointestinal disorders | 7/63 | 3/64 | 1/60 | 21/170 |
| Urinary tract infectionInfections and infestations | 0/63 | 0/64 | 0/60 | 12/170 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/63 | 0/64 | 4/60 | 8/170 |
| ContusionInjury, poisoning and procedural complications | 0/63 | 0/64 | 0/60 | 11/170 |
| DizzinessNervous system disorders | 4/63 | 0/64 | 0/60 | 10/170 |
| Weight decreasedInvestigations | 0/63 | 0/64 | 0/60 | 10/170 |
Demographic Characteristics of intent-to-treat (ITT) Population.
| Age, Categorical(Participants) | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 25 | 24 | 78 |
| >=65 years | 34 | 39 | 33 | 106 |
| Age, Continuous(years) | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total |
|---|---|---|---|---|
| Mean | 62.6 ± 13.0 | 64.6 ± 14.0 | 64.1 ± 13.1 | 63.8 ± 13.4 |
| Sex: Female, Male(Participants) | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total |
|---|---|---|---|---|
| Female | 15 | 9 | 16 | 40 |
| Male | 48 | 55 | 41 | 144 |
| Ethnicity (NIH/OMB)(Participants) | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 1 | 8 |
| Not Hispanic or Latino | 58 | 62 | 56 | 176 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MYOBLOC 2500 U | MYOBLOC 3500 U | PLACEBO | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 1 | 4 |
| White | 60 | 60 | 55 | 175 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
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
Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC