Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT02070302
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2014-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.santimaw@azarthritis.com', 'phone': '4806266653', 'title': 'Amanda Santimaw', 'organization': 'Arizona Arthritis & Rheumatology Research, PLLC'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A', 'description': 'At 18 weeks, mean distal motor latency changes of -0.6 ms (P-value = 0.078) in the Onabot group were noted; and distal sensory latency changes of -0.3ms in the Onabot group; less slowing. Decreased mean cross-sectional area of -2.2 mm2 (P-value =0.040) in Onabot group were noted; less nerve edema. Decreased percent compression of the median nerve during stress testing was -12.6% in Onabot group. Three subjects injected with Onabot demonstrated decreases in median distal motor latencies that were nearly significant (p-value\\<.1, \\>.05), Two had decreases in median distal sensory latencies, and some had decreases in cross-sectional area on NMUS that were nearly significant. One Onabot subject did not show improvement or changes in median distal latencies but remained stable while the non-injected hand worsened with increasing median distal latencies.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Left Neck Pain', 'notes': 'Unrelated to the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck Stiffness', 'notes': 'Unrelated to the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Hand Weakness', 'notes': 'Related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'Rash on Left Groin Area. Not related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '0.4', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline-Week 18', 'description': 'Patients with Levine score \\< 4 were included in the study. The score for this assessment can range from 11-55.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline-Week 18', 'description': 'Patients with Levine score of \\< 4 were included in the study. The score for this assessment can range from 8-40', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '-13.0', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '-15.9', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 18', 'description': 'Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 6, week 12, and week 18.', 'description': 'Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 18', 'description': 'Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'OG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'classes': [{'title': 'Visit 2-Week 6', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-Week 12', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4-Week 18', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline-Week 18', 'description': 'Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.', 'unitOfMeasure': 'Pounds of Force (LBF)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nBotulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each'}, {'id': 'FG001', 'title': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)\n\nPlacebo: Placebo (Normal Saline) divided into 2 injections of .4cc each'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A (Onabot)', 'description': 'A prospective, randomized, double blind pilot study of patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). For 5 out of 10 subjects, non-dominant hands were injected under ultrasound guidance with 40 units of Onabot (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A prospective, randomized, double blind pilot study of 10 patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). Non-dominant hands were injected under ultrasound guidance with 40 units of 40 units of normal saline (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.'}, {'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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '17.9', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '20.3', 'groupId': 'BG001'}, {'value': '56.35', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '10 patients with bilateral CTS, diagnosed by nerve conduction studies and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing), divided into control and Onabot groups. Non-dominant hands were injected under ultrasound guidance with 40 units (0.4 cc) of Onabot or normal saline.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2014-02-20', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-22', 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.', 'timeFrame': 'Baseline-Week 18', 'description': 'Patients with Levine score \\< 4 were included in the study. The score for this assessment can range from 11-55.'}, {'measure': 'Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.', 'timeFrame': 'Baseline-Week 18', 'description': 'Patients with Levine score of \\< 4 were included in the study. The score for this assessment can range from 8-40'}, {'measure': 'Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.', 'timeFrame': 'Baseline to Week 18', 'description': 'Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.'}, {'measure': 'Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.', 'timeFrame': 'Baseline, week 6, week 12, and week 18.', 'description': 'Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline'}, {'measure': 'Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.', 'timeFrame': 'Baseline to Week 18', 'description': 'Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.'}, {'measure': 'Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.', 'timeFrame': 'Baseline-Week 18', 'description': 'Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.', 'detailedDescription': 'This is a pilot study, to assist with determining appropriate BOTOX® (onabotulinumtoxin A) dosing and injection locations in patients suffering from CTS.\n\nOutcome measures will be obtained at follow-up at 6, 12, and 18 weeks post BOTOX® (onabotulinumtoxin A) injection and post saline injection using the same scales and instruments at baseline, namely Levine scale, JAMAR pinch dynamometer, EDX/NCS and NMUS. These measurements will be used to identify the effectiveness of BOTOX® (onabotulinumtoxin A) in decreasing thenar muscle strength, appropriate BOTOX® (onabotulinumtoxin A) injection dosing, and ability to decrease the inflammation, median nerve dysfunction, edema, symptoms of pain, numbness, and tingling often with associated with CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient history: evaluated using the Levine Scale for CTS, a self-administered questionnaire which assesses the function and severity of CTS.\n* Physical Exam: including use of JAMAR pinch dynamometer to quantify initial baseline strength and confirm decreased pinch strength post injection to verify effective BOTOX® (onabotulinumtoxin A) injection.\n* Electrodiagnostics (EDX): The following criteria would establish CTS through EDX namely baseline electromyogram (EMG) and nerve conduction studies (NCS): a) median nerve distal motor latency (DML) \\>4.3ms or \\>0.9ms above the ulnar nerve DML b) median distal sensory latency (DSL) to D-1 \\>2.9ms or \\>0.4ms above radial nerve D-1 DSL. c) median D-2 DSL \\>3.7ms or \\>0.4ms above ulnar nerve D-5 DSL (5). d) median mixed nerve palm-to-wrist latency (at 8cm) \\>2.2ms or \\>.3ms above ulnar mixed nerve palm-to-wrist latency (at 8cm).\n* Imaging \\& Measurements (NMUS): Carpal tunnel images will be obtained in a transverse plane in both a neutral relaxed position at the level of the pisiform and longitudinally during neutral and Dynamic Stress Testing (DST) by a A Sonosite M-Turbo 6-13 MHz ultrasound system or another similar system (+ 2% accuracy). Measurements: Transverse images of the CT will measure the median nerve cross sectional area (CSA) at the level of the pisiform bone. CSA measurements greater than 11 mm2 are indicative of CTS. Borderline CSA measurements would require wrist forearm ratio (WFR) measurements to be a WFR \\> 1.5. Patients will need to have a CSA \\>11mm2, (or WFR \\>1.5) and show median nerve compression during DST of at least 30% to be included.\n\nExclusion Criteria:\n\n* Patients with prior carpal tunnel surgery, prior history of BOTOX® (onabotulinumtoxin A) injection\n* Steroid injection two months prior or three months after BOTOX® (onabotulinumtoxin A) CTS injection, median nerve denervation on needle EMG\n* Major limb trauma or surgery, dysphagia\n* Neuromuscular junction disorder (ie: Myasthenia gravis or Lambert-Eaton syndrome)\n* Currently pregnant or breast feeding\n* Patients with severe CTS identified by Levine scale \\>4, electrodiagnostics, and/or unable to meet the inclusion criteria as identified above would be excluded as participants in this study.'}, 'identificationModule': {'nctId': 'NCT02070302', 'briefTitle': 'BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Arizona Arthritis & Rheumatology Research, PLLC.'}, 'officialTitle': 'BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '85700'}, 'secondaryIdInfos': [{'id': '85700', 'type': 'OTHER_GRANT', 'domain': 'Allergan Sales. LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum Toxin Type A', 'description': 'After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)', 'interventionNames': ['Drug: Botulinum Toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': '40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each', 'armGroupLabels': ['Botulinum Toxin Type A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Placebo (Normal Saline) divided into 2 injections of .4cc each', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Benjamin Sucher, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona Arthritis & Rheumatology Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benjamin Sucher', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin Sucher', 'investigatorAffiliation': 'Arizona Arthritis & Rheumatology Research, PLLC.'}}}}