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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)

Primary Purpose

Cocaine Use, Cocaine Intoxication, Cocaine Toxicity

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TNX-1300 (Injection)
Placebo (Injection)
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Use focused on measuring Emergency Department, Cocaine, Cocaine Intoxication, Cocaine Esterase

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    TNX-1300

    Placebo

    Arm Description

    A single IV 200 mg injection of TNX-1300

    A single IV injection of placebo with UC

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.

    Secondary Outcome Measures

    Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC
    Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing.
    Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing
    Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    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.

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Tonix Pharmaceuticals, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA), Premier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045793
    Brief Title
    Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
    Acronym
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 5, 2023 (Anticipated)
    Primary Completion Date
    June 4, 2024 (Anticipated)
    Study Completion Date
    June 4, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tonix Pharmaceuticals, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA), Premier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction
    Keywords
    Emergency Department, Cocaine, Cocaine Intoxication, Cocaine Esterase

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Patients will be blinded to which treatment arm they are assigned to.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TNX-1300
    Arm Type
    Experimental
    Arm Description
    A single IV 200 mg injection of TNX-1300
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    A single IV injection of placebo with UC
    Intervention Type
    Drug
    Intervention Name(s)
    TNX-1300 (Injection)
    Other Intervention Name(s)
    Cocaine esterase
    Intervention Description
    Patients will receive a single IV injection of TNX-1300.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (Injection)
    Intervention Description
    Patients will receive a single IV injection of placebo with usual care (UC).
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    Description
    Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.
    Time Frame
    60 minutes after IV administration
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC
    Description
    Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing.
    Time Frame
    15 minutes after IV administration
    Title
    Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    Description
    Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing
    Time Frame
    60 minutes after IV administration
    Title
    Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC
    Description
    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.
    Time Frame
    60 minutes after IV administration

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sr. Manager, Clinical Programs
    Phone
    203-482-3938
    Email
    Megha.Tevar@tonixpharma.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Director of Clinical Program Management
    Email
    Ashild.Peters@tonixpharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory Sullivan, MD
    Organizational Affiliation
    Tonix Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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