- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045793
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST) (CATALYST)
November 29, 2023 updated by: Tonix Pharmaceuticals, Inc.
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)
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 Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sr. Manager, Clinical Programs
- Phone Number: 203-482-3938
- Email: Megha.Tevar@tonixpharma.com
Study Contact Backup
- Name: Director of Clinical Program Management
- Email: Ashild.Peters@tonixpharma.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TNX-1300
A single IV 200 mg injection of TNX-1300
|
Patients will receive a single IV injection of TNX-1300.
Other Names:
|
Placebo Comparator: Placebo
A single IV injection of placebo with UC
|
Patients will receive a single IV injection of placebo with usual care (UC).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
60 minutes after IV administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes after IV administration
|
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
|
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
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.
|
60 minutes after IV administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 11, 2023
Primary Completion (Estimated)
June 4, 2024
Study Completion (Estimated)
June 4, 2024
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Estimated)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Poisoning
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Anesthetics, Local
- Dopamine Uptake Inhibitors
- Vasoconstrictor Agents
- Cocaine
Other Study ID Numbers
- TNX-CE-CI202
- 5U01DA056245 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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