Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07526558 · ClinicalTrials.gov registry record · Phase 2
Mast Cell Treatment in Post-tick Bite Illness (PTBI)
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Not yet
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07526558: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT07526558 is a Phase 2 study that has not yet begun recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07526558, a Phase 2 study, has not yet begun recruiting, sponsored by University of North Carolina, Chapel Hill.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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).
Primary Outcome
Symptoms will be assessed using the mast cell activity symptom scale, which is based on the American Academy of Allergy, Asthma and Immunology scale but with modifications to include neuro/psych symptoms. The construct is a Likert metric with participants ranking symptoms based on categories of frequency, severity and impact to daily life ("bothersome"). Each item is rated on a 4-point scale from 1 ("not at all") to 4 ("extremely") resulting in a range of 63 - 252. Higher scores are correlated w
Interventions
- DRUG Ketotifen
- DRUG Cromolyn Sodium
- DRUG fexofenadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What is known before NCT07526558 opens enrollment
NCT07526558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketotifen is the first listed.
NCT07526558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07526558 about?
NCT07526558 is a clinical study titled "Mast Cell Treatment in Post-tick Bite Illness (PTBI)". 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 ...
What is the current status of trial NCT07526558?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-04-30. Estimated completion is 2027-01.
What interventions are being tested in trial NCT07526558?
The interventions under investigation include: Ketotifen (DRUG), Cromolyn Sodium (DRUG), fexofenadine (DRUG).
Who is sponsoring clinical trial NCT07526558?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07526558's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI