Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects (MYSTICOL)

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

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.

Full description

Primary Objective: To determine the efficacy of MYOBLOC (administered via intraglandular as a single total dose of 2,500 Units or 3,500 Units) versus placebo in the treatment of troublesome sialorrhea in adult subjects via the assessment of unstimulated salivary flow rate and clinical global impression of sialorrhea severity and improvement at Week 4 post-injection (Part A). It is hypothesized that both MYOBLOC doses will achieve greater efficacy than placebo in relieving sialorrhea at 4 weeks post-injection.

To compare the safety and tolerability of MYOBLOC versus placebo over a 13 week post-injection period (Part A).

Secondary Objective: To assess the onset and duration of therapeutic response of MYOBLOC using efficacy assessments performed at Weeks 1, 2, 4, 8, and 13 after the first treatment (Part A).

To assess the duration of therapeutic response of MYOBLOC (administered via intraglandular as a single total dose of 3,500 Units) using efficacy assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).

To determine the long-term safety and tolerability of MYOBLOC treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).

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