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 :
Completed
First Posted : November 25, 2013
Results First Posted : August 15, 2019
Last Update Posted : July 13, 2021
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Sponsor:
Supernus Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
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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 : | 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
Drug Information available for:
Rimabotulinumtoxinb
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: MYOBLOC 2500 U
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 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 |
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Placebo Comparator: Placebo
Subjects will receive volume matched Placebo
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Other: PLACEBO
Other Name: volume-matched placebo |
Primary Outcome Measures :
- 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.
- 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
Locations
| United States, California | |
| Loma Linda, California, United States, 92354 | |
| Los Angeles, California, United States, 90033 | |
| National City, California, United States, 91950 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Boca Raton, Florida, United States, 33486 | |
| Port Charlotte, Florida, United States, 33980 | |
| United States, Indiana | |
| Carmel, Indiana, United States, 46032 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| Elkridge, Maryland, United States, 21075 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48334 | |
| United States, Missouri | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Edison, New Jersey, United States, 08818 | |
| United States, New York | |
| Albany, New York, United States, 12208 | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, South Carolina | |
| Port Royal, South Carolina, United States, 29935 | |
| United States, Tennessee | |
| Cordova, Tennessee, United States, 38018 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Kirkland, Washington, United States, 98034 | |
| Tacoma, Washington, United States, 98409 | |
| Russian Federation | |
| Irkutsk, Irkutsk Region, Russian Federation, 664079 | |
| Vsevolozhsk, Leningrad Region, Russian Federation, 188643 | |
| St.Petersburg, Petrodvorets, Russian Federation, 198510 | |
| Krasnoyarsk, Russian Federation, 660037 | |
| Ukraine | |
| Dnipropetrovsk, Ukraine, 49027 | |
| Ivano-Frankivsk, Ukraine, 76008 | |
| Kharkiv, Ukraine, 61068 | |
| Lviv, Ukraine, 79010 | |
| Rivne, Ukraine, 33010 | |
| Uzhgorod, Ukraine, 88018 | |
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
| Study Director: | Najeebah Abdul-Musawir, MD,MBA | Supernus Pharmaceuticals, Inc. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01994109 |
| Other Study ID Numbers: |
SN-SIAL-301 |
| First Posted: | November 25, 2013 Key Record Dates |
| Results First Posted: | August 15, 2019 |
| Last Update Posted: | July 13, 2021 |
| Last Verified: | August 2019 |
Keywords provided by Supernus Pharmaceuticals, Inc.:
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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 rimabotulinumtoxinB Botulinum Toxins Acetylcholine Release Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Anti-Dyskinesia Agents |