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

This study has been completed.
Sponsor:
Collaborators:
ALS Association
University of Kansas
Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00125203
First received: July 27, 2005
Last updated: March 13, 2012
Last verified: March 2012

July 27, 2005
March 13, 2012
July 2003
Not Provided
Global impression of change by subject at eight weeks post injection
Same as current
Complete list of historical versions of study NCT00125203 on ClinicalTrials.gov Archive Site
  • 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
  • -Patient's subjective assessment of benefit
  • -Change in volume of saliva produced over five minutes (measured with funnel and tube)
  • -ALSFRS
  • -Caregiver's subjective assessment of benefit
  • -Change in anticholinergic medication doses and nubmer 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
Not Provided
Not Provided
 
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

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Amyotrophic Lateral Sclerosis
  • Sialorrhea
  • Drug: Botulinum toxin type B (Myobloc)
  • Procedure: Injection of salivary glands
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
Not Provided

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
Both
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125203
BB-IND 11090
Yes
Not Provided
The University of Texas Health Science Center at San Antonio
  • ALS Association
  • University of Kansas
  • Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System
Principal Investigator: Carlayne E Jackson, MD The University of Texas Health Science Center at San Antonio
Principal Investigator: Charles B Simpson, MD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP