CompletedPhase 3

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

United States187 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

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

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

Occurrence of Adverse Events of Special Interest (AESI)

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

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

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

Occurrence of Dental Adverse Events

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

Trial details

NCT IDNCT02610868

SponsorSolstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

Results submitted2019-09-06

View on ClinicalTrials.gov More Sialorrhea trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Occurrence of Adverse Events of Special Interest (AESI)

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

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

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

Occurrence of Dental Adverse Events

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