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NCT Number: NCT01994109

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

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.

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Key information

Conditions

Sialorrhea Amyotrophic Lateral Sclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Metabolic Diseases Motor Neuron Disease Mouth Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinsonian Disorders Proteostasis Deficiencies Salivary Gland Diseases Spinal Cord Diseases Stomatognathic Diseases Stroke Synucleinopathies TDP-43 Proteinopathies Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Irkutsk, Irkutsk Oblast, Russia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MYOBLOC

Drug

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.

Other names: rimabotulinumtoxinB, botulinum toxin type B

Placebo

Other

Other names: volume-matched placebo

Primary outcomes

  1. Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)

    Time frame: 4 Weeks

    Change weight of expectorated saliva at a Week 4 post-injection visit.

  2. Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® Followed by Open-Label, Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

Acronym: MYSTICOL

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Nov 25, 2013
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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