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)

Tonix Pharmaceuticals, Inc.6 sites in 1 country3 target enrollmentAugust 16, 2024

ConditionsCocaine Use Cocaine Intoxication Cocaine Toxicity Cocaine Abuse Cocaine Adverse Reaction

InterventionsTNX-1300 (Injection)Placebo (Injection)

DrugsTNX-1300 (Injection)Placebo (Injection)

Overview

Phase: Phase 2
Intervention: TNX-1300 (Injection)
Conditions: Cocaine Use
Sponsor: Tonix Pharmaceuticals, Inc.
Enrollment: 3
Locations: 6
Primary Endpoint: Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 within the emergency department setting.

Registry

clinicaltrials.gov

Start Date

August 16, 2024

End Date

April 21, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tonix Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≥
•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:

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 (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.

Arms & Interventions

TNX-1300

A single IV 200 mg injection of TNX-1300

Intervention: TNX-1300 (Injection)

Placebo

A single IV injection of placebo with UC

Intervention: Placebo (Injection)

Outcomes

Primary Outcomes

Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

Time Frame: 60 minutes after IV administration

Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.

Secondary Outcomes

Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC(15 minutes after IV administration)
Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC(60 minutes after IV administration)
Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC(60 minutes after IV administration)