Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02610868 | Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults | PHASE3 | COMPLETED | 187 | — | — | Oct 1, 2015 | Jun 1, 2017 | Jul 13, 2021 | 35 | United States, Belarus +1 |
| NCT01994109 | Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects | PHASE3 | COMPLETED | 187 | — | — | Nov 1, 2013 | Jan 1, 2017 | Jul 13, 2021 | 34 | United States, Russia +1 |
TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)
Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.
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).
Treatment Session (TS)
Change weight of expectorated saliva at a Week 4 post-injection visit.
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.
| Arm | Type | Description |
|---|---|---|
| MYOBLOC Injection | EXPERIMENTAL | 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. |
| MYOBLOC 2500 U | ACTIVE_COMPARATOR | Subjects will receive specified dose of MYOBLOC |
| MYOBLOC 3500 U | ACTIVE_COMPARATOR | Subjects will receive specified dose of MYOBLOC |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive volume matched Placebo |
| Name | Type | Description |
|---|---|---|
| MYOBLOC | DRUG | 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 |
| PLACEBO | OTHER | - |
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 i...