CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 187 enrolled
Drug / intervention
MYOBLOCdrug
Likely dose
MYOBLOC 3,500 Unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02610868
NCT02610868Phase 3Completed
CompareCT.gov

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

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC·interventional·Posted Nov 20, 2015·Updated Apr 21, 2026

In Brief

A Phase 3 clinical trial evaluating MYOBLOC for Sialorrhea. Completed, enrolled 187 participants across 35 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSialorrhea
CountriesBelarus, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.6 years ago

Interventions

MYOBLOCdrug

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