Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (MYSTICOL)

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sialorrhea

Treatments: Drug: MYOBLOC; Other: PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994109

SN-SIAL-301

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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187 participants in 3 patient groups, including a placebo group

MYOBLOC 2500 U

Active Comparator group

Description:

Subjects will receive specified dose of MYOBLOC

Treatment:

Drug: MYOBLOC

MYOBLOC 3500 U

Active Comparator group

Description:

Subjects will receive specified dose of MYOBLOC

Treatment:

Drug: MYOBLOC

Placebo

Placebo Comparator group

Description:

Subjects will receive volume matched Placebo

Treatment:

Other: PLACEBO