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

Completed

Phase 3 Results N/A

Trial 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.

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

Interventions

  • MYOBLOC Drug
    Other Names: rimabotulinumtoxinB, botulinum toxin type B
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: MYOBLOC Injection
    Description: 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.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse Events through study completion, up to 1 year Yes
Secondary Adverse Events of Special Interest through study completion, up to 1 year Yes
Secondary Columbia Suicide Rating Scale (C-SSRS) through study completion, up to 1 year Yes
Secondary Occurrence of Dental Adverse Events through study completion, up to 1 year Yes
Secondary Unstimulated Salivary Flow Rate (USFR) through study completion, up to 1 year No
Secondary Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) through study completion, up to 1 year No
Secondary Patient Global Impression of Severity (PGI-S) and Change (PGI-C) through study completion, up to 1 year No
Secondary Drooling Frequency and Severity Scale (DFSS) through study completion, up to 1 year No
Secondary Drooling Impact Score (DIS) through study completion, up to 1 year No

Sponsors