Trials / Terminated
TerminatedNCT06045793
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Tonix Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNX-1300 (Injection) | Patients will receive a single IV injection of TNX-1300. |
| DRUG | Placebo (Injection) | Patients will receive a single IV injection of placebo with usual care (UC). |
Timeline
- Start date
- 2024-08-16
- Primary completion
- 2025-04-21
- Completion
- 2025-04-21
- First posted
- 2023-09-21
- Last updated
- 2025-06-24
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06045793. Inclusion in this directory is not an endorsement.