drugset / Trial / NCT06045793
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
Phase 2
Terminated
3 enrolled
Tonix Pharmaceuticals, Inc.
National Institute on Drug Abuse (NIDA) · collabPremier · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-08-16
- Primary completion
- 2025-04-21
- Completion
- 2025-04-21
Outcome
Outcome not reported
Stopped (Enrollment): “Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TNX-1300 | Unknown | 200 mg | Intravenous |