Status:
TERMINATED
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Premier
Conditions:
Cocaine Use
Cocaine Intoxication
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- Subject is male or female and is 18-64 years of age.
- 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.
- 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:
- Systolic BP \>140 mmHg, or
- 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.
- At Screening and Baseline assessments, subject must have a SIS total score of ≥4
- At Baseline, subject has a CGI-S score ≥3.
- 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).
- Subject must be willing to practice the following:
- If female, practice one of the following methods of birth control throughout the study and for 28 days after study drug administration:
- 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;
- Intrauterine device;
- Bilateral tubal ligation
- Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jelly or cream);
- 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
- Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.
Exclusion
- Subject who has been admitted to the ED involuntarily.
- Subject who participated in this clinical study previously.
- 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).
- 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.
- Subject tests positive for stimulant drugs of abuse other than cocaine, including methylphenidate, 3,4-methylenedioxymethamphetamine, methamphetamine, or other amphetamines at Screening.
- 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.
- 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.
- Subject has a heart rate ≥180 bpm, atrial fibrillation, greater than first degree heart block, or chest pain with ECG-based evidence of ischemia.
- 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.
- Subject has a clinical history of anaphylaxis, severe asthma, hypersensitivity, or angioedema.
- Subject requires physical restraints due to physiological and/or behavioral symptoms.
- Subject receives anti-hypertensive medication(s) in the ED prior to study enrollment.
- Subject is pregnant or breastfeeding.
- Participation in another investigational drug study (current or within 30 days of Screening) or previous participation in a study of TNX-1300.
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06045793
Start Date
August 16 2024
End Date
April 21 2025
Last Update
June 24 2025
Active Locations (6)
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1
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
2
University Of Maryland Medical Center
Baltimore, Maryland, United States, 37601
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Wayne State University
Detroit, Michigan, United States, 48235