NCT04996056

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	TNX-1300	TNX 1300 200 mg Intravenous injection
OTHER	Usual Care	Usual Care per the Emergency Department protocol for Cocaine Intoxication

Timeline

• Start date: 2021-09-03
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2021-08-09
• Last updated: 2022-06-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study