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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125203
• Other study ID #: BB-IND 11090
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 27, 2005
• Last updated: March 13, 2012
• Start date: July 2003
• Est. completion date: August 2007

Study information

• Verified date: March 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis
• Sialorrhea

Intervention

Drug:
• Botulinum toxin type B (Myobloc)

Procedure:
• Injection of salivary glands

Locations

Country	Name	City	State
United States	Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace	Charlotte	North Carolina
United States	University of Kansas Medical Center/Neurology, 1008 Wescoe	Kansas City	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	ALS Association, Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global impression of change by subject at eight weeks post injection
Secondary	Patient's subjective assessment of benefit
Secondary	Change in volume of saliva produced over five minutes (measured with funnel and tube)
Secondary	ALS Functional Rating Scale (ALSFRS)
Secondary	Caregiver's subjective assessment of benefit
Secondary	Change in anticholinergic medication doses and number of times per day suction is used
Secondary	SEQOL-DW
Secondary	Duration of benefit
Secondary	Assessment of treatment assignment (final visit only)
Secondary	Global assessment of change by investigator