Trial | NCT00125203  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rimabotulinumtoxinB ...

  • Study Participants

    20
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.
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 Started
Jul 31
2003
Study Completion
Aug 31
2007
Last Update
Mar 14
2012
Estimate

Drug Botulinum toxin type B (Myobloc)

Procedure Injection of salivary glands

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
No Results Posted