Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT06045793
Status:
TERMINATED
Last Update Posted:
2025-06-24
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'C019921', 'term': 'cocaine esterase'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be blinded to which treatment arm they are assigned to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC', 'timeFrame': '60 minutes after IV administration', 'description': 'Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC', 'timeFrame': '15 minutes after IV administration', 'description': 'Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing.'}, {'measure': 'Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC', 'timeFrame': '60 minutes after IV administration', 'description': 'Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing'}, {'measure': 'Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC', 'timeFrame': '60 minutes after IV administration', 'description': 'Patients will be assessed with the SIS for characterizing severity of cocaine intoxication at Baseline and at 60 minutes after dosing. The SIS has 6 items, each of which is scored on a range of 0-3 (4 items) or 0-4 (2 items). The SIS has a total score range of 0 to 20, with 0 being the lowest severity and 20 being the highest severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Department', 'Cocaine', 'Cocaine Intoxication', 'Cocaine Esterase'], 'conditions': ['Cocaine Use', 'Cocaine Intoxication', 'Cocaine Toxicity', 'Cocaine Abuse', 'Cocaine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female and is 18-64 years of age.\n* Subject has the capacity to provide voluntary written informed consent. In cases in which the investigator is unclear if the subject has the capacity to consent, a determination regarding capacity must be made by a psychiatrist trained in assessment of capacity to consent to research in order for the subject to be eligible.\n* At Screening, subject presents with cardiac symptoms while intoxicated with cocaine, inclusive of elevated systolic or diastolic BP, as defined below, with or without behavioral symptoms:\n\n * Systolic BP \\>140 mmHg, or\n * Diastolic BP \\>90 mmHg Note: subjects with a QT interval corrected for heart rate (QTc) \\>500 msec may be eligible for study participation, based on investigator judgment.\n* At Screening and Baseline assessments, subject must have a SIS total score of ≥4\n* At Baseline, subject has a CGI-S score ≥3.\n* Subject has a positive urine drug screen test at Pre-screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids and/or opioids and remain eligible; subject may test positive for alcohol by breathalyzer and remain eligible).\n* Subject must be willing to practice the following:\n\n * If female, practice one of the following methods of birth control throughout the study and for 28 days after study drug administration:\n * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient\'s usual menstrual cycle period) before study drug administration;\n * Intrauterine device;\n * Bilateral tubal ligation\n * Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jelly or cream);\n * If male, practice double-barrier method throughout the study and for 28 days after study drug administration, if female partner is not following birth control methods a-c mentioned above\n* Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.\n\nExclusion Criteria:\n\n* Subject who has been admitted to the ED involuntarily.\n* Subject who participated in this clinical study previously.\n* Subject has a score of 3 on the systolic and/or diastolic BP SIS components, a "mental state" or "orientation" SIS component score of ≥2, or an "orientation" SIS component score of ≥1 and the subject is not oriented to either person or place (i.e., only disorientation to time is allowed).\n* Subject who, at Screening, expresses C-SSRS suicidal ideation of Type 4 or 5 in the prior week or any C-SSRS suicidal behavior in the prior week.\n* Subject tests positive for stimulant drugs of abuse other than cocaine, including methylphenidate, 3,4-methylenedioxymethamphetamine, methamphetamine, or other amphetamines at Screening.\n* Subject has a clinically significant untreated cardiac condition, such as prior myocardial infarction, current ischemia assessed by ECG-based criteria, aortic dissection, ventricular fibrillation, Torsade de pointes, ventricular tachycardia, cardiomyopathy, pulmonary edema, cardiac arrest, significant conduction disturbance (e.g., greater than first degree heart block), QRS interval \\>120 msec, or severe or life-threatening hypertension. Untreated hypertension may be allowed if not considered severe or life-threatening. Note: hypertension will be considered severe or life-threatening if systolic BP is \\>200 mmHg and/or diastolic BP is \\>130 mmHg.\n* Subject incurred or is likely to incur a myocardial infarction or other life-threatening severe event or has acute ECG changes indicative of acute coronary syndrome according to investigator judgment. Such changes may include new, transient, or dynamic ST-segment elevation, ST-depression, or significant Q waves. Based on investigator judgement, T-wave inversion and T-wave flattening may also be considered in the risk assessment for acute coronary syndrome.\n* Subject has a heart rate ≥180 bpm, atrial fibrillation, greater than first degree heart block, or chest pain with ECG-based evidence of ischemia.\n* Subject has a clinically significant or unstable medical illness, condition, or disorder that can compromise subject safety or adversely affect the evaluation of clinical outcome parameters.\n* Subject has a clinical history of anaphylaxis, severe asthma, hypersensitivity, or angioedema.\n* Subject requires physical restraints due to physiological and/or behavioral symptoms.\n* Subject receives anti-hypertensive medication(s) in the ED prior to study enrollment.\n* Subject is pregnant or breastfeeding.\n* Participation in another investigational drug study (current or within 30 days of Screening) or previous participation in a study of TNX-1300.'}, 'identificationModule': {'nctId': 'NCT06045793', 'acronym': 'CATALYST', 'briefTitle': 'Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tonix Pharmaceuticals, Inc.'}, 'officialTitle': 'A Single-Blind, Randomized Study Comparing The Efficacy And Safety Of A Single Dose Of TNX-1300 To Placebo With Usual Care For The Treatment Of Signs And Symptoms Of Acute Cocaine Intoxication In Emergency Department Subjects (CATALYST Study)', 'orgStudyIdInfo': {'id': 'TNX-CE-CI202'}, 'secondaryIdInfos': [{'id': '5U01DA056245', 'link': 'https://reporter.nih.gov/quickSearch/5U01DA056245', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNX-1300', 'description': 'A single IV 200 mg injection of TNX-1300', 'interventionNames': ['Drug: TNX-1300 (Injection)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single IV injection of placebo with UC', 'interventionNames': ['Drug: Placebo (Injection)']}], 'interventions': [{'name': 'TNX-1300 (Injection)', 'type': 'DRUG', 'otherNames': ['Cocaine esterase'], 'description': 'Patients will receive a single IV injection of TNX-1300.', 'armGroupLabels': ['TNX-1300']}, {'name': 'Placebo (Injection)', 'type': 'DRUG', 'description': 'Patients will receive a single IV injection of placebo with usual care (UC).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Chandler Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '37601', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University Of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48235', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine, Ben Taub Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gregory Sullivan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tonix Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tonix Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Premier', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}