Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT06045793
Status:
TERMINATED
Last Update Posted:
2025-06-24
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
Sponsor:
Tonix Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATALYST
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5U01DA056245 | NIH | None | https://reporter.nih.gov/quic… | View |