Nebulized dexmedetomidine for early chronic migraine
Official title: Effect of Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine: A Randomized Controlled Trial Using Calcitonin Gene Related Peptide and Trigeminal Neurophysiological Biomarkers
Run by Beni-Suef University · NCT07769255 · Data updated 2026-11-12
This study tests whether inhaled dexmedetomidine can lessen central sensitization and help prevent chronification in people with early chronic migraine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 10, 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07769255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with early chronic migraine (<6 months of having 15+ headache days per month) who have not used preventive migraine therapies in the last 8 weeks.
✕Probably not a fit
Patients with significant cardiopulmonary, psychiatric, or neurological conditions, or those using sedatives, opioids, or CGRP-targeting therapies, may not benefit or could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will administer nebulized dexmedetomidine to adults with early chronic migraine, defined as 15 or more headache days per month for at least 3 months with migraine features on most days. The goal is to see if the treatment reduces central sensitization in the trigeminovascular system, potentially lowering pain intensity and frequency. The approach relies on the central antinociceptive effects of dexmedetomidine delivered via inhalation to achieve rapid CNS exposure with minimal sedation. Participants must not have recent preventive therapy or conflicting comorbidities, and will be evaluated for changes in migraine activity and associated sensitization markers. The sponsor is Beni-Suef University, and the study is conducted at Beni-Suef University Hospital in Banī Suwayf, Egypt.
Why it matters
Potential benefit: If successful, patients may experience fewer migraine days and less sensitivity to sensory stimuli.
How similar studies have gone: Prior work suggests dexmedetomidine can reduce central sensitization, but nebulized delivery for migraine chronification is a novel approach with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Early chronic migraine (\<6 months of ≥15 headache days/month), per ICHD-3 criteria. * No preventive migraine therapy in the prior 8 weeks. Exclusion Criteria: * Presence of cardiopulmonary, psychiatric, or neurological comorbidities. * Current use of sedatives, opioids, or CGRP-targeting therapies. * Pregnancy or breastfeeding.
Where it's running
-
Beni-Suef University Hospital
Banī Suwayf, Egypt Recruiting
Study contacts
- Study coordinator: Ibthal Osama Fathy Ibrahim, MSc
- Email: Ibthal21@gmail.com
- Phone: +201098273360
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
i-NEED: New migraine drugs database
This project will collect real-life data to see how new migraine treatments—anti‑CGRP antibodies, gepants, ditans, and a sumatriptan‑naproxen combo—work and how well adults with episodic or chronic migraine tolerate them.
-
Suppressive Functions of Regulatory T Cells in Migraine
This study tests whether regulatory T cells can help control migraine-related inflammation in adults with chronic migraine.
-
Comparing sphenopalatine block and BOTOX for chronic migraine relief
This study is testing whether a nerve block or BOTOX injections can help people with chronic migraines feel better.
-
Using Atogepant tablets to prevent migraines in teens aged 12 to 17
This study is testing if Atogepant tablets can help prevent migraines in teenagers aged 12 to 17.
-
Acceptance and Commitment Therapy to reduce disability in adults with chronic migraine
This trial will test whether adding Acceptance and Commitment Therapy (ACT) to usual care helps adults with chronic migraine improve daily functioning and reduce headache frequency and pain.
-
Comparing nerve block injections to Botox for chronic migraine relief
This study tests whether nerve block injections or Botox can help adults with chronic migraines feel better and have fewer migraine days.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.