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

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ClinicalTrials.gov Identifier: NCT01994109
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : August 15, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Sialorrhea Drug: MYOBLOC Other: PLACEBO Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MYOBLOC 2500 U
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
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 Name: rimabotulinumtoxinB, botulinum toxin type B

Active Comparator: MYOBLOC 3500 U
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
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 Name: rimabotulinumtoxinB, botulinum toxin type B

Placebo Comparator: Placebo
Subjects will receive volume matched Placebo
Other: PLACEBO
Other Name: volume-matched placebo




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994109


  Show 34 Study Locations
Sponsors and Collaborators
US WorldMeds LLC
Investigators
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Study Director: Cynthia A Rask, MD US WorldMeds

Publications of Results:
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Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT01994109     History of Changes
Other Study ID Numbers: SN-SIAL-301
First Posted: November 25, 2013    Key Record Dates
Results First Posted: August 15, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Keywords provided by US WorldMeds LLC:
Sialorrhea
Parkinson's disease
Amyotrophic lateral sclerosis (ALS)
stroke
neuroleptics
Additional relevant MeSH terms:
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Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
rimabotulinumtoxinB
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents