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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by US WorldMeds LLC
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC
ClinicalTrials.gov Identifier:
NCT01994109
First received: November 14, 2013
Last updated: April 25, 2014
Last verified: February 2014
  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

Contacts
Contact: Jeremy Call 502-714-7826 jcall@usworldmeds.com
Contact: Robert Chinnapongse, MD rchinnapongse@usworldmeds.com

Locations
United States, California
Not yet recruiting
Los Angeles, California, United States
Recruiting
San Diego, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Boca Raton, Florida, United States
Recruiting
Port Charlotte, Florida, United States
United States, Maryland
Not yet recruiting
Baltimore, Maryland, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Missouri
Recruiting
St Louis, Missouri, United States
United States, New York
Recruiting
Albany, New York, United States
Recruiting
New York City, New York, United States
United States, Ohio
Recruiting
Cleveland, Ohio, United States
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States
United States, South Carolina
Recruiting
Port Royal, South Carolina, United States
United States, Texas
Withdrawn
Dallas, Texas, United States
Recruiting
Houston, Texas, United States
Recruiting
San Antonio, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Washington
Recruiting
Kirkland, Washington, United States
Recruiting
Tacoma, Washington, United States
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: April 25, 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:
RimabotulinumtoxinB
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014