Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT00125203
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00125203
Study Brief:
Protocol Section:
NCT00125203