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

NCT ID: NCT00125203

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2007-08-31

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.

Conditions

Amyotrophic Lateral Sclerosis; Sialorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Botulinum toxin type B (Myobloc)

Intervention Type: DRUG

Injection of salivary glands

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: collaborator

Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Principal Investigators

Carlayne E Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Charles B Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Kansas Medical Center/Neurology, 1008 Wescoe

Kansas City, Kansas, United States

Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

BB-IND 11090

Identifier Type: -

Identifier Source: org_study_id