Amyotrophic Lateral Sclerosis, Sialorrhea
Conditions
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
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.
Interventions
PROCEDUREInjection of salivary glands
Sponsors
ALS Association
University of Kansas
Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global impression of change by subject at eight weeks post injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Patient's subjective assessment of benefit | — |
| Duration of benefit | — |
| Assessment of treatment assignment (final visit only) | — |
| Global assessment of change by investigator | — |
| SEQOL-DW | — |
Countries
United States
Outcome results
None listed