Clinical trial NCT06045793: Comparing Efficacy & Safety of TNX-1300 to Placebo with UC for Treatment of Acute Cocaine Intoxication in ED Subjects (CATALYST)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cocaine Use
Cocaine Intoxication
Cocaine Toxicity
Cocaine Abuse
Cocaine Adverse Reaction
Keywords: Emergency Department
Cocaine
Cocaine Intoxication
Cocaine Esterase
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Premier
First posted: 2023-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 ≥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 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.
* 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.

Primary outcomes:
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
Secondary outcomes:
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
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
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
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: University Of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Houston
country: United States
facility: Baylor College of Medicine, Ben Taub Hospital
state: Texas
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: