NCT06045793TerminatedPhase 2
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 enrollmentStarted: August 16, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients will be blinded to which treatment arm they are assigned to.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
Arms & Interventions
TNX-1300
Experimental
A single IV 200 mg injection of TNX-1300
Intervention: TNX-1300 (Injection) (Drug)
Placebo
Placebo Comparator
A single IV injection of placebo with UC
Intervention: Placebo (Injection) (Drug)
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)
Investigators
Study Sites (6)
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