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

Completed · Phase 2/Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis, Sialorrhea

In brief

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.

Key facts

Study ID

NCT00125203

Run by

The University of Texas Health Science Center at San Antonio

People needed

20

Starts

2003-07-01

Expected to finish

2007-08-01

Last updated by the study team

2012-03-14

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center/Neurology, 1008 Wescoe — Kansas City, Kansas, United States
• Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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