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

The University of Texas System (UT)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Sialorrhea

Amyotrophic Lateral Sclerosis

Treatments

Drug: Botulinum toxin type B (Myobloc)

Procedure: Injection of salivary glands

Study type

Interventional

Funder types

Other

Identifiers

BB-IND 11090

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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