NCT00125203CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
The University of Texas Health Science Center at San Antonio2 sites in 1 country20 target enrollmentStarted: July 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Global impression of change by subject at eight weeks post injection
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Global impression of change by subject at eight weeks post injection
Secondary Outcomes
- 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
Investigators
Study Sites (2)
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