Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT02015234
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004704', 'term': 'cyclobenzaprine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'greg.sullivan@tonixpharma.com', 'phone': '212 980 9155', 'title': 'Gregory M. Sullivan, Chief Medical Officer', 'phoneExt': '117', 'organization': 'Tonix Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'An industry standard NDA in place with all study investigators.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': '5% was used as the adverse event reporting cut-off', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 43, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 39, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 10}], 'organSystem': 'Infections and infestations'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Brain stem glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Pubic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.'}, {'id': 'OG001', 'title': 'TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.'}], 'classes': [{'title': 'Patient with at least 1 NEAE reported', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Patients withdrew due to NEAE', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Patient with at least 1 SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.'}, {'id': 'OG001', 'title': 'TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 3, 6, 9 and 12.', 'description': 'The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.'}, {'id': 'OG001', 'title': 'TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.'}, {'type': 'SECONDARY', 'title': "Responder Analysis of Patient's Global Impression of Change (PGIC)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.'}, {'id': 'OG001', 'title': 'TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.'}], 'classes': [{'title': 'Month 1', 'categories': [{'title': 'Score 1 or 2', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Scores 3 to 7', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'title': 'Score 1 or 2', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Scores 3 to 7', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'title': 'Score 1 or 2', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Scores 3 to 7', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'categories': [{'title': 'Score 1 or 2', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Scores 3 to 7', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'title': 'Score 1 or 2', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Scores 3 to 7', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 1, 3, 6, 9, 12', 'description': "PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. Overall, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study early. Any missing PGIC responses were included in the "scores 3-7" for that visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': 'These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.'}, {'id': 'FG001', 'title': 'TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg', 'description': 'These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'One hundred fifty-eight (158) of the 174 patients who completed 12 weeks of treatment in Study F202 were eligible and consented to participate in the 12-month safety extension study.', 'preAssignmentDetails': 'Restricted to patients who completed the lead-in double-blind study and continued to meet the inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo - TNX-102 SL 2.8 mg', 'description': '1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months\n\nTNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime.'}, {'id': 'BG001', 'title': 'TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg', 'description': '1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months\n\nTNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime.'}, {'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': '75', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '65'}, {'value': '51.7', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '64'}, {'value': '50.9', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2013-12-09', 'resultsFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-08', 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.', 'timeFrame': 'Up to 12 months', 'description': 'NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall', 'timeFrame': 'Months 1, 3, 6, 9 and 12.', 'description': 'The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.'}, {'measure': 'Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.'}, {'measure': "Responder Analysis of Patient's Global Impression of Change (PGIC)", 'timeFrame': 'Months 1, 3, 6, 9, 12', 'description': "PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TNX-102 SL', 'bedtime', 'sublingual', '12-month', 'long term safety', 'long term efficacy', 'Fibromyalgia'], 'conditions': ['Primary Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.', 'detailedDescription': 'The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.\n\nPrimary:\n\nThe primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)\n\nSecondary:\n\nThe secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.\n2. The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.\n3. The patient has provided written informed consent to participate in this extension protocol.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02015234', 'acronym': 'BESTFIT-OLE', 'briefTitle': '12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tonix Pharmaceuticals, Inc.'}, 'officialTitle': 'A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'TNX-CY-F203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNX-102 SL', 'description': '1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months', 'interventionNames': ['Drug: TNX-102 SL']}], 'interventions': [{'name': 'TNX-102 SL', 'type': 'DRUG', 'otherNames': ['cyclobenzaprine HCl'], 'description': 'TNX-102 SL 2.8 mg taken daily at bedtime.', 'armGroupLabels': ['TNX-102 SL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34601', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': '16176 Cortez Boulevard', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': '100 West Gore Street', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': '71 Thomas Johnson Drive', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': '370 Faunce Corner Road', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': '1275 Olentangy River Road', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': '18660 Bagley Road', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '17055', 'city': 'Mechanicsburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '1001 South Market Street', 'geoPoint': {'lat': 40.21426, 'lon': -77.00859}}, {'zip': '29650', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': '322 Memorial Drive', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': '601 Broadway', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Gregory Sullivan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tonix Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tonix Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}