Status:
COMPLETED
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
ALS Association
University of Kansas
Conditions:
Amyotrophic Lateral Sclerosis
Sialorrhea
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
PHASE3
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 ...
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 object...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00125203
Start Date
July 1 2003
End Date
August 1 2007
Last Update
March 14 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center/Neurology, 1008 Wescoe
Kansas City, Kansas, United States, 66160-7314
2
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
Charlotte, North Carolina, United States, 28203