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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis Sialorrhea	Drug: Botulinum Toxin Type B (Myobloc)  Procedure: Injection of salivary glands	Phase I

Further Study Details: 

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); -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
Expected Total Enrollment:  20

The secondary goals of this study are to: 1) determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea 2) determine by objective measures if the Myobloc injection decreases the saliva produced 3) determine caregiver perceived benefit from Myobloc injection

Ages Eligible for Study:  21 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: -Diagnosis of probable or definite ALS based on current World Federation of Neurology driteria -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 on other experimental protocols -cannot provide informed consent or comply wit 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 adequte form of birth control -currently being treated with coumadin -forced vital capacity (FVC) <20% 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00125203

Carlayne E Jackson, MD      210-567-1945    jacksonce@uthscsa.edu
Pamela P Kittrell, MSN      210-567-1979    kittrellp@uthscsa.edu

Kansas
      University of Kansas Medical Center/Neurology, 1008 Wescoe, Kansas City,  Kansas,  66160-7314,  United States; Recruiting
North Carolina
      Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace, Charlotte,  North Carolina,  28203,  United States; Recruiting

Study chairs or principal investigators

Carlayne E Jackson, MD,  Principal Investigator,  The University of Texas Health Science Center as San Antonio   
Charles B Simpson, MD,  Principal Investigator,  The University of Texas Health Science Center at San Antonio   

Study ID Numbers:  BB-IND 11090
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02