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 |
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Recruitment Status
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Completed
First Posted
: November 25, 2013
Last Update Posted
: October 27, 2017
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Sponsor:
US WorldMeds LLC
Information provided by (Responsible Party):
US WorldMeds LLC
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 157 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: MYOBLOC Dose 1
Subjects will receive specified dose of MYOBLOC
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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
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Active Comparator: MYOBLOC Dose 2
Subjects will receive specified dose of MYOBLOC
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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
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Placebo Comparator: Placebo
Subjects will receive volume matched Placebo
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Other: PLACEBO
Other Name: volume-matched placebo
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Primary Outcome Measures
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- Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ]
Secondary Outcome Measures
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- Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ]
Other Outcome Measures:
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ]Adverse events and adverse events of special interest will be assessed at each study visit. Adverse events may be assessed by subject report, review of symptoms, vital signs, laboratory values, physical examination, neurological examination, dental examination and the review of the Columbia Suicide Severity Rating Scale (C-SSRS)
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| 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
| Study Director: | Cynthia A Rask, MD | US WorldMeds |
Publications of Results:
| 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 |
| Last Update Posted: | October 27, 2017 |
| Last Verified: | October 2017 |
Keywords provided by US WorldMeds LLC:
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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 Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA abobotulinumtoxinA rimabotulinumtoxinB |
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 |