Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

• Status: Not yet recruiting
• Trial end date: 2024-06-04
• Target enrollment: 0
• Participant gender: Male

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 within the emergency department setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Premier
• Treatments: Cocaine

Criteria

Inclusion Criteria:

• Subject is male (sex assigned at birth).

• Subject 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 and diastolic BP, as defined below, with or without behavioral symptoms:

• Systolic BP >140 mmHg

• 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 and a score >1 on at least one of the 2 BP items (systolic and diastolic BP).

• 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 is a suitable candidate for investigational treatment based on the opinion of the investigator.

Exclusion Criteria:

• 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.

• 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 or severe left ventricular hypertrophy 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.

• Participation in another investigational drug study (current or within 30 days of Screening) or previous participation in a study of TNX-1300.