Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 1:16 AM
Study NCT ID:
NCT00125203
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2005-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 a benefit from the Myobloc in controlling excessive drooling.
The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
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 objective measures if the Myobloc injection decreases the saliva produced;
* determine caregiver perceived benefit from Myobloc injection.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: