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Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125203
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : March 14, 2012
Sponsor:
Collaborators:
ALS Association
University of Kansas
Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
Information provided by:
The University of Texas Health Science Center at San Antonio

Study Description
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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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Sialorrhea Drug: Botulinum toxin type B (Myobloc) Procedure: Injection of salivary glands Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Global impression of change by subject at eight weeks post injection

Secondary Outcome Measures :
  1. Patient's subjective assessment of benefit
  2. Change in volume of saliva produced over five minutes (measured with funnel and tube)
  3. ALS Functional Rating Scale (ALSFRS)
  4. Caregiver's subjective assessment of benefit
  5. Change in anticholinergic medication doses and number of times per day suction is used
  6. SEQOL-DW
  7. Duration of benefit
  8. Assessment of treatment assignment (final visit only)
  9. Global assessment of change by investigator

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125203


Locations
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United States, Kansas
University of Kansas Medical Center/Neurology, 1008 Wescoe
Kansas City, Kansas, United States, 66160-7314
United States, North Carolina
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
ALS Association
University of Kansas
Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
Investigators
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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
More Information
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ClinicalTrials.gov Identifier: NCT00125203    
Other Study ID Numbers: BB-IND 11090
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012
Keywords provided by The University of Texas Health Science Center at San Antonio:
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
Additional relevant MeSH terms:
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Sialorrhea
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Salivary Gland Diseases
Mouth Diseases
 Stomatognathic Diseases
rimabotulinumtoxinB
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents