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

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ClinicalTrials.gov Identifier: NCT06045793
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : December 1, 2023
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Premier
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Use Cocaine Intoxication Cocaine Toxicity Cocaine Abuse Cocaine Adverse Reaction Drug: TNX-1300 (Injection) Drug: Placebo (Injection) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patients will be blinded to which treatment arm they are assigned to.
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 11, 2023
Estimated Primary Completion Date : June 4, 2024
Estimated Study Completion Date : June 4, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TNX-1300
A single IV 200 mg injection of TNX-1300
 Drug: TNX-1300 (Injection)
Patients will receive a single IV injection of TNX-1300.
Other Name: Cocaine esterase
Placebo Comparator: Placebo
A single IV injection of placebo with UC
 Drug: Placebo (Injection)
Patients will receive a single IV injection of placebo with usual care (UC).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC [ Time Frame: 15 minutes after IV administration ]
    Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing.

  2. Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC [ Time Frame: 60 minutes after IV administration ]
    Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing

  3. Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC [ Time Frame: 60 minutes after IV administration ]
    Patients will be assessed with the SIS for characterizing severity of cocaine intoxication at Baseline and at 60 minutes after dosing. The SIS has 6 items, each of which is scored on a range of 0-3 (4 items) or 0-4 (2 items). The SIS has a total score range of 0 to 20, with 0 being the lowest severity and 20 being the highest severity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045793


Contacts
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Contact: Sr. Manager, Clinical Programs 203-482-3938 Megha.Tevar@tonixpharma.com
Contact: Director of Clinical Program Management Ashild.Peters@tonixpharma.com

Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
National Institute on Drug Abuse (NIDA)
Premier
Investigators
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Study Director: Gregory Sullivan, MD Tonix Pharmaceuticals
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT06045793    
Other Study ID Numbers: TNX-CE-CI202
5U01DA056245 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
Emergency Department
Cocaine
Cocaine Intoxication
Cocaine Esterase
Additional relevant MeSH terms:
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Poisoning
Cocaine-Related Disorders
Chemically-Induced Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents