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

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis; Sialorrhea

• Registration Number: NCT00125203
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-29
• Study Completion: 2007-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global impression of change by subject at eight weeks post injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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