Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (MYSTICOL)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by US WorldMeds LLC
Sponsor:
US WorldMeds LLC
Information provided by (Responsible Party):
US WorldMeds LLC
ClinicalTrials.gov Identifier:
NCT01994109
First received: November 14, 2013
Last updated: December 8, 2014
Last verified: December 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sialorrhea |
Drug: MYOBLOC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by US WorldMeds LLC:
Primary Outcome Measures:
- Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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)
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2013 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: MYOBLOC Dose 1
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. It is currently indicated in the United States for the treatment of cervical dystonia.
Other Name: rimabotulinumtoxinB, botulinum toxin type B
|
|
Active Comparator: MYOBLOC Dose 2
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. It is currently indicated in the United States for the treatment of cervical dystonia.
Other Name: rimabotulinumtoxinB, botulinum toxin type B
|
| Placebo Comparator: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994109
Show 26 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994109
Contacts
| Contact: Nikki Hutchins | 502-815-8122 | nhutchins@usworldmeds.com | |
| Contact: Robert Chinnapongse, MD | rchinnapongse@usworldmeds.com |
Show 26 Study Locations
Sponsors and Collaborators
US WorldMeds LLC
Investigators
| Study Director: | Robert Chinnapongse, MD | US WorldMeds LLC |
More Information
Publications:
| Responsible Party: | US WorldMeds LLC |
| ClinicalTrials.gov Identifier: | NCT01994109 History of Changes |
| Other Study ID Numbers: | SN-SIAL-301 |
| Study First Received: | November 14, 2013 |
| Last Updated: | December 8, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by US WorldMeds LLC:
|
Sialorrhea Parkinson's disease Amyotrophic lateral sclerosis (ALS) stroke neuroleptics |
Additional relevant MeSH terms:
|
Sialorrhea Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Botulinum Toxins |
RimabotulinumtoxinB Anti-Dyskinesia Agents Central Nervous System Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015