AzTrials
AzTrials

SialorrheaPhase 3OPTIMYSTNCT02610868

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

A Phase 3 study testing MYOBLOC in people with Sialorrhea, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC at 35 sites in 3 countries.

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

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 more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Sialorrhea
What is being tested?
MYOBLOC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
35 sitesin 3 countries
Study dates
Oct 2015to Jun 2017
Phase
Phase 3
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

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

35 sites in 3 countries.

35 sites in 3 countries

United States26 sites

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Cordova, Tennessee, 38018

  • Study site

    Edison, New Jersey, 08818

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Farmington Hills, Michigan, 48334

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Las Vegas, Nevada, 89145

  • Study site

    Loma Linda, California, 92354

  • Study site

    Los Angeles, California, 90033

  • Study site

    Orlando, Florida, 32806

  • Study site

    Overland Park, Kansas, 66211

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    Spokane, Washington, 99202

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tacoma, Washington, 98409

  • Study site

    Tulsa, Oklahoma, 74136

Other trials in United States

Ukraine8 sites

  • Study site

    Dnipropetrovsk, 49027

  • Study site

    Ivano-Frankivsk, 76008

  • Study site

    Kharkiv, 61068

  • Study site

    Lviv, 79010

  • Study site

    Odesa, 65025

  • Study site

    Rivne, 33010

  • Study site

    Uzhhorod, 88018

  • Study site

    Zaporizhzhya, 69600

Other trials in Ukraine

Belarus1 site

  • Study site

    Grodno, 230017

Other trials in Belarus

About this study

Official title: A Phase 3, Long-Term, Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

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.

Conditions
Sialorrhea
Being tested
MYOBLOC
Keywords
Cerebral Palsy, ALS, Stroke, Neuroleptics
Medical subject headings
Sialorrhea, Cerebral Palsy, Stroke

What participants receive

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

  • MYOBLOCDrug

    Also called rimabotulinumtoxinB, botulinum toxin type B

    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

Study groups in NCT02610868
Study groupRoleWhat they receive
MYOBLOC InjectionExperimentalAfter a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections over the course of 1 year.
Receives: Drug: MYOBLOC

What is being measured

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

  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)

    Measured: 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.

    Measured: 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).

    Measured: 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)

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

Secondary outcomes (8)

  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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

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

  1. First posted20 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610868
Sponsor's protocol ID
SN-SIAL-351
Acronym
OPTIMYST
Status last verified
Mar 2026
First submitted
2 Nov 2015
Last updated
21 Apr 2026
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYOBLOC in people with Sialorrhea, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC at 35 sites in 3 countries.

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 6 inclusion and 14 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 35 sites in United States, Ukraine, Belarus. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 4 Nov 2019). 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?

Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) (time frame: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1). The study lists 4 primary outcomes in all. 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 NCT02610868, which also lists 1 linked publication.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in