Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 12:16 AM
Study NCT ID:
NCT00908050
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2009-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety and Efficacy of Botox in Bruxism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wondo@houstonmethodist.org', 'phone': '713-363-8390', 'title': 'William Ondo, MD', 'organization': 'Baylor College of Medicine/Houston Methodist'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo arm\n\nBaseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria.', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Botulinum Toxin Type A', 'description': 'Active arm\n\nBaseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'temporal-mandibular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cosmetic change in smile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bruxism Questionnaire Baseline and at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo arm at baseline\n\nBaseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\].'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A at Baseline', 'description': 'Active arm\n\nBaseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\].'}, {'id': 'OG002', 'title': 'Placebo Arm at Week 4', 'description': 'Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\].'}, {'id': 'OG003', 'title': 'Botulinum Toxin Type A at Week 4', 'description': 'Active arm\n\nBaseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '5.4', 'groupId': 'OG002'}, {'value': '24.0', 'spread': '6.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0394', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus week 4', 'description': 'Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Bruxism questionnaire comparison at Week 4 in placebo versus active treatment group.'}, {'type': 'SECONDARY', 'title': 'Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo arm at baseline\n\nBaseline assessments included a HIT-6 questionnaire.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A at Baseline', 'description': 'Active arm\n\nBaseline assessments included a HIT-6 questionnaire.'}, {'id': 'OG002', 'title': 'Placebo Arm at Week 4', 'description': 'Baseline assessments included a HIT-6 questionnaire.'}, {'id': 'OG003', 'title': 'Botulinum Toxin Type A at Week 4', 'description': 'Active arm\n\nBaseline assessments included a HIT-6 questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '59.2', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '51.2', 'spread': '11.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 4', 'description': 'Baseline assessments included HIT-6 questionnaire. This is compared to week 4 assessments. The Headache Impact Test consists of 6 questions. Each question can be scored between 6 to 13 points for a possible total of 78 points. A total score of 50 or more means the patient has migraines. A score of 49 or less means the patient has headaches, not migraines. The minimum score if 36. The maximum score is 78 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'HIT-6 questionnaire comparison at Week 4 in placebo versus active treatment group.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo arm at baseline\n\nBaseline assessments included a CGI questionnaire.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A at Baseline', 'description': 'Active arm\n\nBaseline assessments included a CGI questionnaire.'}, {'id': 'OG002', 'title': 'Placebo Arm at Week 4', 'description': 'Baseline assessments included a CGI questionnaire.'}, {'id': 'OG003', 'title': 'Botulinum Toxin Type A at Week 4', 'description': 'Active arm\n\nBaseline assessments included a CGI questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '2', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus week 4', 'description': 'With this scale the clinical evaluates the patient and gives the patient a single score based off of the evaluation. The score given can be between 1 and 7 where 1 means the patient is normal and 7 means the patient is amongst the most severely ill. The minimum score if 1. The maximum score is 7.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CGI questionnaire comparison at Week 4 in placebo versus active treatment group.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Change (VAS)-Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo arm at baseline\n\nBaseline assessments included a VAS-bruxism questionnaire.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A at Baseline', 'description': 'Active arm\n\nBaseline assessments included a VAS-bruxism questionnaire.'}, {'id': 'OG002', 'title': 'Placebo Arm at Week 4', 'description': 'Baseline assessments included a VAS-bruxism questionnaire.'}, {'id': 'OG003', 'title': 'Botulinum Toxin Type A at Week 4', 'description': 'Active arm\n\nBaseline assessments included a VAS-bruxism questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '17.8', 'groupId': 'OG001'}, {'value': '45.8', 'spread': '19.6', 'groupId': 'OG002'}, {'value': '48.6', 'spread': '13.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline versus week 4', 'description': 'Visual Analog scale of change (VAS) (0-100) comparing delta of pre-versus post-injection.The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum score if 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'VAS-pain scale questionnaire comparison at Week 4 in placebo versus active treatment group.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Change (VAS)-Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo arm at baseline\n\nBaseline assessments included a VAS-pain questionnaire.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A at Baseline', 'description': 'Active arm\n\nBaseline assessments included a VAS-pain questionnaire.'}, {'id': 'OG002', 'title': 'Placebo Arm at Week 4', 'description': 'Baseline assessments included a VAS-pain questionnaire.'}, {'id': 'OG003', 'title': 'Botulinum Toxin Type A at Week 4', 'description': 'Active arm\n\nBaseline assessments included a VAS-pain questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '48.6', 'spread': '13.6', 'groupId': 'OG002'}, {'value': '65', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus week 4', 'description': 'The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum sore if 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'VAS-pain questionnaire comparison at Week 4 in placebo versus active treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo arm'}, {'id': 'FG001', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin type A (BOTOX)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Thirty-one subjects were recruited but eight were excluded: 3 prior to randomization/PSG (withdrew consent), 5 before randomization/after PSG (3 for lack of bruxism on PSG, 2 for severe obstructive sleep apnea on PSG with an AHI \\> 30 / hr).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo arm\n\nWe performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011.'}, {'id': 'BG001', 'title': 'Botulinum Toxin Type A', 'description': 'Active arm\n\nWe performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Thirty-one subjects were recruited, eight were excluded: 3 (withdrew consent), 5 after PSG (3 for lack of bruxism on PSG, 2 severe OSA on PSG with an AHI \\> 30 / hr). 19 females were randomized. 21 reported some temporal-mandibular pain. 13 randomized to BoNT-A and 10 randomized to placebo \\& completed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2009-05-21', 'resultsFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2009-05-22', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-15', 'studyFirstPostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bruxism Questionnaire Baseline and at Week 4', 'timeFrame': 'baseline versus week 4', 'description': 'Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \\[Lavigne G. with permission\\]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.'}], 'secondaryOutcomes': [{'measure': 'Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4', 'timeFrame': 'Baseline to week 4', 'description': 'Baseline assessments included HIT-6 questionnaire. This is compared to week 4 assessments. The Headache Impact Test consists of 6 questions. Each question can be scored between 6 to 13 points for a possible total of 78 points. A total score of 50 or more means the patient has migraines. A score of 49 or less means the patient has headaches, not migraines. The minimum score if 36. The maximum score is 78 points.'}, {'measure': 'Clinical Global Impression (CGI)', 'timeFrame': 'baseline versus week 4', 'description': 'With this scale the clinical evaluates the patient and gives the patient a single score based off of the evaluation. The score given can be between 1 and 7 where 1 means the patient is normal and 7 means the patient is amongst the most severely ill. The minimum score if 1. The maximum score is 7.'}, {'measure': 'Visual Analog Scale of Change (VAS)-Pain Scale', 'timeFrame': 'baseline versus week 4', 'description': 'Visual Analog scale of change (VAS) (0-100) comparing delta of pre-versus post-injection.The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum score if 100.'}, {'measure': 'Visual Analog Scale of Change (VAS)-Pain', 'timeFrame': 'Baseline versus week 4', 'description': 'The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum sore if 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bruxism, botulinum toxin, sleep study'], 'conditions': ['Bruxism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.', 'detailedDescription': 'Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism but it may result in tooth damage, jaw pain, headaches, poor quality sleep and may bother your partner\'s sleep at night due to the tooth grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and several medications have been tried, but they generally did not work or caused side effects.\n\nBotulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very small amounts. It is currently approved and used for the treatment of various conditions involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes, and it has also been used cosmetically for wrinkle removal.\n\nSince bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been tried, initial results showing that it is safe and effective. The injections generally take one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks, and slowly wear off. The injections are generally repeated every 3-4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.\n* 2\\. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of contraception (hormonal contraceptives, spermicidal barrier, intrauterine device, partner sterility) at least one month prior to study entry. Any female of childbearing age will have a urine pregnancy test one week prior to the treatment (visit 2).\n* 3\\. Ability of the patient or guardian to sign and understand informed consent.\n* 4\\. Ability to follow and comply with study directions.\n\nExclusion Criteria:\n\n* 1\\. Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.\n* 2\\. Coexistence of serious co-morbid conditions.\n* 3\\. Exposure to any botulinum toxin preparation within the past 6 months.\n* 4\\. Participation in another experimental therapeutic protocol within 30 days.\n* 5\\. Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.\n* 6\\. History of dysphagia.\n* 7\\. History of botulism.\n* 8\\. A condition or situation in which the investigators view will confound the ability of the subject to participate in the study.\n* 9\\. Patients or guardian who are unable to understand and sign informed consent.\n* 10\\. Pregnancy\n* 11\\. Patients who do not meet inclusion criteria.\n* 12\\. Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.'}, 'identificationModule': {'nctId': 'NCT00908050', 'briefTitle': 'Study of the Safety and Efficacy of Botox in Bruxism', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Double-blind, Placeboa-controlled, Randomized Clinical Trial of the Safety and Efficacy of Botulinum Toxin (BOTOX) in Bruxism.', 'orgStudyIdInfo': {'id': 'H-22737'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo arm', 'interventionNames': ['Drug: Placebo arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'botulinum toxin type A', 'description': 'Active arm', 'interventionNames': ['Drug: Botulinum toxin type A']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'otherNames': ['Botulinum toxin type A (Botox)'], 'description': 'Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.', 'armGroupLabels': ['botulinum toxin type A']}, {'name': 'Placebo arm', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William G Ondo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joseph Jankovic', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}