Overview

This trial is active, not recruiting.

Condition sialorrhea
Treatments myobloc, placebo
Phase phase 3
Sponsor US WorldMeds LLC
Start date November 2013
End date January 2016
Trial size 180 participants
Trial identifier NCT01994109, SN-SIAL-301

Summary

This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Subjects will receive specified dose of MYOBLOC
myobloc rimabotulinumtoxinB, botulinum toxin type B
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
(Active Comparator)
Subjects will receive specified dose of MYOBLOC
myobloc rimabotulinumtoxinB, botulinum toxin type B
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
(Placebo Comparator)
Subjects will receive volume matched Placebo
placebo volume-matched placebo

Primary Outcomes

Measure
Unstimulated Salivary Flow Rate
time frame: 4 Weeks

Secondary Outcomes

Measure
Clinical Global Impression Change (CGI-C)
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause - Investigator sites will review entire list of inclusion criteria with potential subjects Exclusion Criteria: - Any known prior exposure to botulinum toxin type B, or known adverse reaction or sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components. - Prior botulinum toxin treatment to the salivary glands at any time - Investigator sites will review entire list of exclusion criteria with potential subjects

Additional Information

Official title A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® (Part A) Followed by Open-Label, Multiple-Treatment With MYOBLOC® (Part B) in the Treatment of Troublesome Sialorrhea in Adult Subjects
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by US WorldMeds LLC.