Back to resultsStudy of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis, Sialorrhea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type B (Myobloc)
Injection of salivary glands
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Lou Gehrig's Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Sialorrhea, Hypersalivation, Excessive Drooling, Myobloc, botulinum toxin type B, Clostridium botulinum B toxin, botulinum B toxin, botulinum neurotoxin B, NeuroBloc
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria Between the ages of 21-85, inclusive Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects Capable of giving informed consent Must be able to attend all study visits Exclusion Criteria: Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days History of ongoing substance abuse History of non-compliance with treatment in other experimental protocols Cannot provide informed consent or comply with evaluation procedures Has received any form of botulinum toxin in the past for any indication Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control Currently being treated with coumadin Forced vital capacity (FVC) <40% of predicted unless the tidal volume is > 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity
Sites / Locations
- University of Kansas Medical Center/Neurology, 1008 Wescoe
- Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
Outcomes
Primary Outcome Measures
Global impression of change by subject at eight weeks post injection
Secondary Outcome Measures
Patient's subjective assessment of benefit
Change in volume of saliva produced over five minutes (measured with funnel and tube)
ALS Functional Rating Scale (ALSFRS)
Caregiver's subjective assessment of benefit
Change in anticholinergic medication doses and number of times per day suction is used
SEQOL-DW
Duration of benefit
Assessment of treatment assignment (final visit only)
Global assessment of change by investigator
Full Information
NCT ID
NCT00125203
First Posted
July 27, 2005
Last Updated
March 13, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
ALS Association, University of Kansas, Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
1. Study Identification
Unique Protocol Identification Number
NCT00125203
Brief Title
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
ALS Association, University of Kansas, Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling.
The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
Detailed Description
The secondary goals of this study are to:
determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
determine by objective measures if the Myobloc injection decreases the saliva produced;
determine caregiver perceived benefit from Myobloc injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, Sialorrhea
Keywords
ALS, Lou Gehrig's Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Sialorrhea, Hypersalivation, Excessive Drooling, Myobloc, botulinum toxin type B, Clostridium botulinum B toxin, botulinum B toxin, botulinum neurotoxin B, NeuroBloc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type B (Myobloc)
Intervention Type
Procedure
Intervention Name(s)
Injection of salivary glands
Primary Outcome Measure Information:
Title
Global impression of change by subject at eight weeks post injection
Secondary Outcome Measure Information:
Title
Patient's subjective assessment of benefit
Title
Change in volume of saliva produced over five minutes (measured with funnel and tube)
Title
ALS Functional Rating Scale (ALSFRS)
Title
Caregiver's subjective assessment of benefit
Title
Change in anticholinergic medication doses and number of times per day suction is used
Title
SEQOL-DW
Title
Duration of benefit
Title
Assessment of treatment assignment (final visit only)
Title
Global assessment of change by investigator
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
Between the ages of 21-85, inclusive
Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
Capable of giving informed consent
Must be able to attend all study visits
Exclusion Criteria:
Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
History of ongoing substance abuse
History of non-compliance with treatment in other experimental protocols
Cannot provide informed consent or comply with evaluation procedures
Has received any form of botulinum toxin in the past for any indication
Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
Currently being treated with coumadin
Forced vital capacity (FVC) <40% of predicted unless the tidal volume is > 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlayne E Jackson, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles B Simpson, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center/Neurology, 1008 Wescoe
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
Facility Name
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
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