An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

NCT04996056 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TNX-CE-CI201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

Conditions

Cocaine Intoxication

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions

  Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions

  Baseline to 12 Hours

Secondary Outcomes (2)

• Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)

  Baseline to 6 Hours

• Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline

  Baseline to 6 Hours

Study Arms (2)

TNX-1300

EXPERIMENTAL

TNX-1300 Intravenous injection 200 mg once over 2 mins

Drug: TNX-1300

Usual Care

OTHER

Usual Care per the Emergency Department protocol for treating Cocaine Intoxication

Other: Usual Care

Interventions

TNX-1300 DRUG

TNX 1300 200 mg Intravenous injection

TNX-1300

Usual Care OTHER

Usual Care per the Emergency Department protocol for Cocaine Intoxication

Usual Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is male (sex assigned at birth).
• Subject is 18-50 years of age.
• Subject has the capacity to provide voluntary written informed consent.
• At Screening, subject presents with a SIS total score of ≥6 and a score \>1 on at least 1 of the 3 cardiovascular items (HR, systolic and diastolic BP).
• At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms.
• Subject has a positive urine drug screen test at Screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids or opiates).
• Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.

You may not qualify if:

• Subject who has been admitted to the ED involuntarily.
• Subject who participated in this clinical study previously.
• Subject received naloxone (Narcan) within 3 hours prior to informed consent.
• Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening.
• Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening.
• 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.
• Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of clinical outcome parameters.
• Subject requires physical restraints due to physiological and/or behavioral symptoms.
• Participation in another investigational drug study (current or within 30 days of Screening).

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

• Gregory Sullivan, MD

  Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 9, 2021
• Study Start: September 3, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

US (2)