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CompletedNCT02610868OPTIMYSTUpdated Apr 21, 2026Results posted

Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults

A Phase 3 interventional study of MYOBLOC in Sialorrhea, sponsored by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC. Completed at 35 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

Phase
Phase 3
Study type
Interventional
Enrollment
187
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.

Read the detailed description

Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary goal is to determine the long-term safety and tolerability of MYOBLOC (administered intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 1 year.

02

Conditions studied

  • Sialorrhea

Keywords

  • Cerebral Palsy
  • ALS
  • Stroke
  • Neuroleptics
03

In context

Sialorrhea

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 →

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.

04

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

  • 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 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

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 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- medications are not specifically exclusionary
  • Evidence of any 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
187 participants (actual)

Study arms

  • Experimental
    MYOBLOC Injection

    After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections over the course of 1 year.

    Drug: MYOBLOC

Interventions

  • DrugMYOBLOC

    After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47

    Also known as: rimabotulinumtoxinB, botulinum toxin type B

06

What researchers measure

Primary outcomes

  1. Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)

    TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)

    Time frame: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

  2. Occurrence of Adverse Events of Special Interest (AESI)

    Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.

    Time frame: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

  3. Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores

    Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  4. Occurrence of Dental Adverse Events

    Treatment Session (TS)

    Time frame: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

Secondary outcomes

  1. Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4

    For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  2. Change From Baseline in Clinical Global Impression of Severity (CGI-S)

    CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  3. Clinical Global Impression of Change (CGI-C)

    CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS)

    Time frame: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  4. Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)

    The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  5. Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)

    The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  6. Change From Baseline in Patient Global Impression of Severity (PGI-S)

    The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  7. Patient Global Impression of Change (PGI-C)

    The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

    Time frame: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

  8. Change From Baseline in Drooling Impact Score (DIS)

    The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities). Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome.

    Time frame: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

07

Results

Posted Nov 4, 2019

Participant flow

Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.

MYOBLOC: Treatment Session 1
Participant flow — MYOBLOC: Treatment Session 1
MilestoneMYOBLOC: 3500U
Started187
Completed180
Not completed7
MYOBLOC: Treatment Session 2
Participant flow — MYOBLOC: Treatment Session 2
MilestoneMYOBLOC: 3500U
Started177
Completed165
Not completed12
MYOBLOC: Treatment Session 3
Participant flow — MYOBLOC: Treatment Session 3
MilestoneMYOBLOC: 3500U
Started50
Completed43
Not completed7
MYOBLOC: Treatment Session 4
Participant flow — MYOBLOC: Treatment Session 4
MilestoneMYOBLOC: 3500U
Started24
Completed22
Not completed2

Outcome measures

PrimaryOccurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)

TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)

Time frame:
Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1
Reported as:
Number · participants
Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)
participantsTreatment Session 1Treatment Session 2Treatment Session 3Treatment Session 4
Serious TEAEs71432
Severe TEAEs5822
TEAEs Related to Study Medication422642
PrimaryOccurrence of Adverse Events of Special Interest (AESI)

Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.

Time frame:
Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1
Reported as:
Number · participants
Occurrence of Adverse Events of Special Interest (AESI)
participantsTreatment Session 1Treatment Session 2Treatment Session 3Treatment Session 4
Aspiration0100
Aspirational pneumonia0100
Choking0000
Dysphagia4000
PrimaryColumbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores

Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Number · participants
Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores
participantsTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Suicidal Ideation220010000
Suicidal Behavior000000000
PrimaryOccurrence of Dental Adverse Events

Treatment Session (TS)

Time frame:
Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1
Reported as:
Number · participants
Occurrence of Dental Adverse Events
participantsTreatment Session 1Treatment Session 2Treatment Session 3Treatment Session 4
Occurrence of Dental Adverse Events272382
SecondaryChange From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4

For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · g/minute
Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4
g/minuteTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4-0.3424 ± 0.3685-0.2771 ± 0.3144-0.1357 ± 0.2888-0.2272 ± 0.2668-0.0560 ± 0.2067-0.1797 ± 0.1975-0.0547 ± 0.2269-0.1592 ± 0.2305-0.0335 ± 0.1378
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = 0.0006
  • Treatment Session 3: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 13 · ANCOVA · p = 0.1131
  • Treatment Session 4: Week 4 · ANCOVA · p = 0.0026
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.2569
SecondaryChange From Baseline in Clinical Global Impression of Severity (CGI-S)

CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Clinical Global Impression of Severity (CGI-S)-1.7 ± 1.26-1.5 ± 1.22-0.9 ± 1.03-0.8 ± 1.12-0.1 ± 0.99-0.9 ± 1.13-0.2 ± 0.90-0.9 ± 0.95-0.3 ± 1.02
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = 0.3130
  • Treatment Session 3: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 13 · ANCOVA · p = 0.1054
  • Treatment Session 4: Week 4 · ANCOVA · p = 0.0002
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.1663
SecondaryClinical Global Impression of Change (CGI-C)

CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS)

Time frame:
TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Clinical Global Impression of Change (CGI-C)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Clinical Global Impression of Change (CGI-C)2.3 ± 0.942.4 ± 1.073.0 ± 1.162.4 ± 1.043.1 ± 1.342.4 ± 0.943.0 ± 1.062.5 ± 0.932.8 ± 0.94
SecondaryChange From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)

The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)-2.3 ± 1.53-2.0 ± 1.52-1.2 ± 1.37-1.2 ± 1.52-0.2 ± 1.30-1.1 ± 1.360.0 ± 1.33-1.5 ± 1.44-0.3 ± 0.71
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = 0.1100
  • Treatment Session 3: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 13 · ANCOVA · p = 1.0000
  • Treatment Session 4: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.0290
SecondaryChange From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)

The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)-1.4 ± 1.35-1.7 ± 1.58-1.0 ± 1.49-0.7 ± 0.90-0.3 ± 0.98-0.4 ± 0.640.0 ± 1.00-0.4 ± 1.03-0.2 ± 1.37
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 4 · ANCOVA · p = 0.0003
  • Treatment Session 3: Week 13 · ANCOVA · p = 0.9016
  • Treatment Session 4: Week 4 · ANCOVA · p = 0.0753
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.4992
SecondaryChange From Baseline in Patient Global Impression of Severity (PGI-S)

The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Change From Baseline in Patient Global Impression of Severity (PGI-S)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Patient Global Impression of Severity (PGI-S)-1.59 ± 1.548-1.41 ± 1.461-0.80 ± 1.364-0.78 ± 1.303-0.07 ± 1.245-0.94 ± 1.2480.04 ± 1.242-1.38 ± 1.279-0.26 ± 1.251
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = 0.4567
  • Treatment Session 3: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 13 · ANCOVA · p = 0.8115
  • Treatment Session 4: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.3282
SecondaryPatient Global Impression of Change (PGI-C)

The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Time frame:
TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Patient Global Impression of Change (PGI-C)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Patient Global Impression of Change (PGI-C)2.5 ± 1.072.7 ± 1.083.0 ± 1.132.6 ± 1.063.2 ± 1.282.7 ± 0.953.2 ± 1.102.5 ± 0.723.4 ± 0.72
SecondaryChange From Baseline in Drooling Impact Score (DIS)

The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities). Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome.

Time frame:
Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13
Reported as:
Mean · units on a scale
Change From Baseline in Drooling Impact Score (DIS)
units on a scaleTreatment Session 1: Week 4Treatment Session 1: Week 8Treatment Session 1: Week 13Treatment Session 2: Week 4Treatment Session 2: Week 13Treatment Session 3: Week 4Treatment Session 3: Week 13Treatment Session 4: Week 4Treatment Session 4: Week 13
Change From Baseline in Drooling Impact Score (DIS)-5.2 ± 5.33-5.4 ± 5.16-3.4 ± 4.97-2.5 ± 4.170.3 ± 3.94-2.8 ± 3.39-0.1 ± 2.11-3.6 ± 3.10-0.5 ± 2.57
Statistical analysis
  • Treatment Session 1: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 8 · ANCOVA · p = <0.0001
  • Treatment Session 1: Week 13 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 2: Week 13 · ANCOVA · p = 0.3786
  • Treatment Session 3: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 3: Week 13 · ANCOVA · p = 0.7787
  • Treatment Session 4: Week 4 · ANCOVA · p = <0.0001
  • Treatment Session 4: Week 13 · ANCOVA · p = 0.3825

Adverse events

Collected over through study completion, up to 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MYOBLOC: Treatment Session 11/187 (0.5%)9/187 (4.8%)44/187 (23.5%)
MYOBLOC: Treatment Session 24/177 (2.3%)18/177 (10.2%)34/177 (19.2%)
MYOBLOC: Treatment Session 32/50 (4%)4/50 (8%)7/50 (14%)
MYOBLOC: Treatment Session 41/24 (4.2%)2/24 (8.3%)4/24 (16.7%)
ALL MYOBLOC: Treatment Sessions 1-48/187 (4.3%)33/187 (17.6%)73/187 (39%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventMYOBLOC: Treatment Session 1MYOBLOC: Treatment Session 2MYOBLOC: Treatment Session 3MYOBLOC: Treatment Session 4ALL MYOBLOC: Treatment Sessions 1-4
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1871/1770/501/242/187
Amyotrophic lateral sclerosisNervous system disorders0/1872/1771/501/244/187
Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1871/1771/500/243/187
PneumoniaInfections and infestations0/1872/1771/500/243/187
MalnutritionMetabolism and nutrition disorders0/1870/1771/500/241/187
Angina pectorisCardiac disorders2/1870/1770/500/242/187
Atrial fibrillationCardiac disorders0/1871/1770/500/241/187
Coronary artery diseaseCardiac disorders0/1871/1770/500/241/187
ContusionInjury, poisoning and procedural complications0/1871/1770/500/241/187
FallInjury, poisoning and procedural complications0/1871/1770/500/241/187
Most frequent other events
Most frequent other events
EventMYOBLOC: Treatment Session 1MYOBLOC: Treatment Session 2MYOBLOC: Treatment Session 3MYOBLOC: Treatment Session 4ALL MYOBLOC: Treatment Sessions 1-4
Dry mouthGastrointestinal disorders29/18710/1771/500/2433/187
Dental cariesGastrointestinal disorders13/18717/1776/502/2432/187
Amyotrophic lateral sclerosisNervous system disorders2/1877/1770/502/248/187

Baseline characteristics

Eligible subjects included male or females aged 18 to 85 years who are seeking treatment for troublesome sialorrhea for at least 3 months before screening.

Age, Categorical
Age, Categorical(Participants)MYOBLOC
<=18 years0
Between 18 and 65 years85
>=65 years102
Sex: Female, Male
Sex: Female, Male(Participants)MYOBLOC
Female58
Male129
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MYOBLOC
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American9
White175
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)MYOBLOC
United States68
Ukraine80
Belarus39
Unstimulated Salivary Flow Rate (USFR)
Unstimulated Salivary Flow Rate (USFR)(g/minute)MYOBLOC
Mean0.6322 ± 0.4918
Clinical Global Impression of Severity (CGI-S)
Clinical Global Impression of Severity (CGI-S)(units on a scale (1-7))MYOBLOC
Mean4.4 ± 0.94
Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity (PGI-S)(units on a scale (1-7))MYOBLOC
Mean5.3 ± 1.2
08

Study locations

35 sites
  • Phoenix, Arizona 85013, United States
  • Scottsdale, Arizona 85258, United States
  • Scottsdale, Arizona 85259, United States
  • Loma Linda, California 92354, United States
  • Los Angeles, California 90033, United States
  • Aurora, Colorado 80045, United States
  • Atlantis, Florida 33462, United States
  • Boca Raton, Florida 33486, United States
  • Orlando, Florida 32806, United States
  • Port Charlotte, Florida 33980, United States
  • Atlanta, Georgia 30329, United States
  • Kansas City, Kansas 66160, United States
  • Overland Park, Kansas 66211, United States
  • Elkridge, Maryland 21075, United States
  • Farmington Hills, Michigan 48334, United States
  • St Louis, Missouri 63110, United States
  • Las Vegas, Nevada 89145, United States
  • Edison, New Jersey 08818, United States
  • Centerville, Ohio 45459, United States
  • Tulsa, Oklahoma 74136, United States
  • Greenville, South Carolina 29615, United States
  • Cordova, Tennessee 38018, United States
  • San Antonio, Texas 78229, United States
  • Kirkland, Washington 98034, United States
  • Spokane, Washington 99202, United States
  • Tacoma, Washington 98409, United States
  • Grodno, 230017, Belarus
  • Dnipropetrovsk, 49027, Ukraine
  • Ivano-Frankivsk, 76008, Ukraine
  • Kharkiv, 61068, Ukraine
  • Lviv, 79010, Ukraine
  • Odesa, 65025, Ukraine
  • Rivne, 33010, Ukraine
  • Uzhhorod, 88018, Ukraine
  • Zaporizhzhya, 69600, Ukraine
09

References and documents

Publications

  • Pahwa R, Molho E, Lew M, Dashtipour K, Gil RA, Revilla FJ, Clinch T, Qin P, Isaacson SH; OPen Label Trial of Intraglandular MYobloc injections for Sialorrhea Treatment (OPTIMYST) study group. Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial. Neurol Ther. 2025 Aug;14(4):1553-1567. doi: 10.1007/s40120-025-00777-z. Epub 2025 Jun 11. PubMed 40498248 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

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 ↗
11

Registry details

Key details

Study ID
NCT02610868
Lead sponsor
Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
Responsible party
Sponsor
First posted
Nov 20, 2015
Start date
Oct 2015
Primary completion
Jun 2017
Completion
Jun 2017
Results posted
Nov 4, 2019
Last update
Apr 21, 2026

Study contacts

Jonathan Rubin, PhD
study director · Supernus Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
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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