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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis, Sialorrhea

Intervention / Treatment
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* Drug: Botulinum toxin type B (Myobloc)
* Procedure: Injection of salivary glands


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin type B (Myobloc)|nan|
|Procedure: Injection of salivary glands|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global impression of change by subject at eight weeks post injection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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