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Sponsors and Collaborators: |
The University of Texas Health Science Center at San Antonio ALS Association University of Kansas Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00125203 |
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 |
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Amyotrophic Lateral Sclerosis Sialorrhea |
Drug: Botulinum toxin type B (Myobloc) Procedure: Injection of salivary glands |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | August 2007 |
The secondary goals of this study are to:
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
University of Kansas Medical Center/Neurology, 1008 Wescoe | |
Kansas City, Kansas, United States, 66160-7314 | |
United States, North Carolina | |
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace | |
Charlotte, North Carolina, United States, 28203 |
Principal Investigator: | Carlayne E Jackson, MD | The University of Texas Health Science Center at San Antonio |
Principal Investigator: | Charles B Simpson, MD | The University of Texas Health Science Center at San Antonio |
Study ID Numbers: | BB-IND 11090 |
Study First Received: | July 27, 2005 |
Last Updated: | May 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00125203 |
Health Authority: | United States: Food and Drug Administration |
ALS Lou Gehrig's Disease Motor Neuron Disease Amyotrophic Lateral Sclerosis Sialorrhea Hypersalivation Excessive Drooling |
Myobloc botulinum toxin type B Clostridium botulinum B toxin botulinum B toxin botulinum neurotoxin B NeuroBloc |
Mouth Diseases Sialorrhea Spinal Cord Diseases Central Nervous System Diseases Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease |
Botulinum Toxins Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Lou Gehrig's disease Stomatognathic Diseases Motor Neuron Disease Salivary Gland Diseases |
Pathologic Processes Anti-Dyskinesia Agents Therapeutic Uses |
Nervous System Diseases Central Nervous System Agents Pharmacologic Actions |