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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D012798', 'term': 'Sialorrhea'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096323', 'term': 'rimabotulinumtoxinB'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2005-07-27', 'studyFirstSubmitQcDate': '2005-07-27', 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global impression of change by subject at eight weeks post injection'}], 'secondaryOutcomes': [{'measure': "Patient's subjective assessment of benefit"}, {'measure': 'Change in volume of saliva produced over five minutes (measured with funnel and tube)'}, {'measure': 'ALS Functional Rating Scale (ALSFRS)'}, {'measure': "Caregiver's subjective assessment of benefit"}, {'measure': 'Change in anticholinergic medication doses and number of times per day suction is used'}, {'measure': 'SEQOL-DW'}, {'measure': 'Duration of benefit'}, {'measure': 'Assessment of treatment assignment (final visit only)'}, {'measure': 'Global assessment of change by investigator'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Sialorrhea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling.\n\nThe primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.', 'detailedDescription': 'The secondary goals of this study are to:\n\n* determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;\n* determine by objective measures if the Myobloc injection decreases the saliva produced;\n* determine caregiver perceived benefit from Myobloc injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria\n* Between the ages of 21-85, inclusive\n* Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects\n* Capable of giving informed consent\n* Must be able to attend all study visits\n\nExclusion Criteria:\n\n* Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days\n* History of ongoing substance abuse\n* History of non-compliance with treatment in other experimental protocols\n* Cannot provide informed consent or comply with evaluation procedures\n* Has received any form of botulinum toxin in the past for any indication\n* Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control\n* Currently being treated with coumadin\n* 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'}, 'identificationModule': {'nctId': 'NCT00125203', 'briefTitle': 'Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': 'BB-IND 11090'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Botulinum toxin type B (Myobloc)', 'type': 'DRUG'}, {'name': 'Injection of salivary glands', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160-7314', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center/Neurology, 1008 Wescoe', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Carlayne E Jackson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}, {'name': 'Charles B Simpson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'ALS Association', 'class': 'OTHER'}, {'name': 'University of Kansas', 'class': 'OTHER'}, {'name': 'Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System', 'class': 'UNKNOWN'}]}}}