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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2007 by The University of Texas Health Science Center at San Antonio. Recruitment status was Active, not recruiting

First Received on July 27, 2005. Last Updated on May 7, 2007 History of Changes

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
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00125203

Purpose

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	Intervention	Phase
Amyotrophic Lateral Sclerosis Sialorrhea	Drug: Botulinum toxin type B (Myobloc) Procedure: Injection of salivary glands	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Botox

Drug Information available for: Botulinum toxin A Botulin B Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

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

Estimated Enrollment:	20
Study Start Date:	July 2003
Estimated Study Completion Date:	August 2007

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.

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125203

Locations

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

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00125203 History of Changes
Other Study ID Numbers:	BB-IND 11090
Study First Received:	July 27, 2005
Last Updated:	May 7, 2007
Health Authority:	United States: Food and Drug Administration

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:

Amyotrophic Lateral Sclerosis
Sclerosis
Sialorrhea
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

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 February 09, 2012