An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual … (NCT04996056) | Clinical Trial Compass
WithdrawnPhase 2
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
Stopped: Not able to recruit qualified participants
United States0Started 2021-09-03
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
✕. 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.