Clinical trial NCT01994109: Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sialorrhea
Keywords: Sialorrhea
Parkinson's disease
Amyotrophic lateral sclerosis (ALS)
stroke
neuroleptics
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
timeFrame: 4 Weeks
measure: Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: National City
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Carmel
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Edison
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Port Royal
country: United States
state: South Carolina
city: Cordova
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Irkutsk
country: Russian Federation
state: Irkutsk Region
city: Vsevolozhsk
country: Russian Federation
state: Leningrad Region
city: St.Petersburg
country: Russian Federation
state: Petrodvorets
city: Krasnoyarsk
country: Russian Federation
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Lviv
country: Ukraine
city: Rivne
country: Ukraine
city: Uzhgorod
country: Ukraine
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Najeebah Abdul-Musawir, MD,MBA
role: STUDY_DIRECTOR
References:
citation: Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial. Mov Disord. 2012 Feb;27(2):219-26. doi: 10.1002/mds.23929. Epub 2011 Sep 1.
citation: Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004 Jan 13;62(1):37-40. doi: 10.1212/01.wnl.0000101713.81253.4c.
citation: Isaacson SH, Ondo W, Jackson CE, Trosch RM, Molho E, Pagan F, Lew M, Dashtipour K, Clinch T, Espay AJ; MYSTICOL Study Group. Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial. JAMA Neurol. 2020 Apr 1;77(4):461-469. doi: 10.1001/jamaneurol.2019.4565.