drugset / Trial / NCT07526558
Mast Cell Treatment in Post-tick Bite Illness (PTBI)
Phase 2
Not yet recruiting
50 enrolled
University of North Carolina, Chapel Hill
Columbia University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).
Timeline
- Start
- 2026-04-30
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cromolyn | Small molecule | 200 mg | Oral |
| Subject | Ketotifen | Small molecule | 2 mg | Oral |
| Background | Fexofenadine | Unknown | 180 mg | Oral |