- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125203
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
March 13, 2012 updated by: The University of Texas Health Science Center at San Antonio
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160-7314
- University of Kansas Medical Center/Neurology, 1008 Wescoe
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Global impression of change by subject at eight weeks post injection
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Secondary Outcome Measures
Outcome Measure |
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Patient's subjective assessment of benefit
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Change in volume of saliva produced over five minutes (measured with funnel and tube)
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ALS Functional Rating Scale (ALSFRS)
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Caregiver's subjective assessment of benefit
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Change in anticholinergic medication doses and number of times per day suction is used
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SEQOL-DW
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Duration of benefit
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Assessment of treatment assignment (final visit only)
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Global assessment of change by investigator
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carlayne E Jackson, MD, The University of Texas Health Science Center at San Antonio
- Principal Investigator: Charles B Simpson, MD, The University of Texas Health Science Center at San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
July 27, 2005
First Submitted That Met QC Criteria
July 27, 2005
First Posted (ESTIMATE)
July 29, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Salivary Gland Diseases
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Sialorrhea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Anti-Dyskinesia Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- rimabotulinumtoxinB
Other Study ID Numbers
- BB-IND 11090
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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