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RecruitingNCT07769255Updated Aug 17, 2026

Effect of Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine

An interventional study of Dexmedetomidine in Chronic Migraine, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Migraine Disorders with a site in Egypt — 17 open to participants now, 18 under way, 2 of them phase 3. Migraine Disorders · Egypt.

Planned enrollment
9th of 23
146 · median 90
Started
2026
with 3 others
No phase
13 of 29
10 open now
Primary completion
2027-03
later than 17 of 17 live
Registered
28th of 29
by date
Lead sponsor
4 of 29
Beni-Suef University

Among the 29 studies in Migraine Disorders with a site in Egypt, this one is the 9th largest by planned enrollment of the 23 interventional ones, is one of 4 that started in 2026, is one of 13 with no phase, reaches primary completion later than 17 of the 17 other live ones, and was the 28th registered.

By phase

29 studies; the count open now beside each. This study's row is marked.

No phasethis study13 · 10 open
Observational6 · 1 open
Phase 36 · 2 open
Phase 44 · 4 open

By the year they started

First in 2019; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 90 across the 23 interventional studies, 103 across the 6 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 29 studies in Migraine Disorders with a site in Egypt, or all of them as a file.
02

Study summary

Migraine is a debilitating neurological disorder characterized by recurrent headaches episodes, often accompanied by amplified perception of multiple sensory inputs such as cutaneous allodynia, photophobia, and phonophobia. The suggested mechanism in migraine is likely through sensitized trigeminovascular and dysfunctional pain modulatory systems.

Dexmedetomidine, a selective α2-adrenergic receptor agonist, exerts central antinociceptive effects by reducing neuronal hyperexcitability, glial activation, and CGRP expression. Nebulized administration provides a non-invasive alternative to intravenous use, with rapid CNS absorption and minimal sedation .

Read the detailed description

Chronic migraine: This is defined as a headache that occurs on 15 or more days in a month for more than 3 months, with migraine features present on at least 8 or more days in a month. Episodic syndromes that may be associated with migraine include recurrent gastrointestinal disturbances, involving recurrent attacks of abdominal pain, discomfort, nausea, and vomiting that may be associated with migraines; benign paroxysmal vertigo involving brief, recurrent attacks of vertigo, or benign paroxysmal torticollis is characterized by recurrent episodes of head tilt to one side.

Migraine chronification is strongly associated with central sensitization of the trigeminovascular system, a process mediated by the upregulation of calcitonin gene-related peptide (CGRP) and enhanced excitability of both brainstem and cortical pain-processing structures. Elevated CGRP plays a pivotal role in migraine pathophysiology by promoting vasodilation, neurogenic inflammation, and nociceptive facilitation.

Calcitonin gene-related peptide is a 37-amino acid neuropeptide and a potent vasodilator produced by neurons in both the central and peripheral nervous systems. Activation of CGRP-R in the trigeminovascular system plays a critical role in peripheral and central events that ultimately lead to the experience of migraine pain .

Following nerve stimulation, CGRP is released from its storage vesicles through the process of calcium-dependent exocytosis.This peripheral release of CGRP from trigeminal nerve endings is thought to trigger multiple responses induced by CGRP-R binding, which eventually lead to the sensitization of nociceptor trigeminal neurons.

The stimulation of peripheral nociceptive trigeminal neurons is hypothesized to relay the migraine pain signal through the brainstem into the brain, ultimately leading to the experience of migraine pain.

Central effects of CGRP may involve pain transmission through sensitization and activation of central processes (eg, feedback from a sensitized brain).

Objective neurophysiological biomarkers such as the nociceptive blink reflex (nBR) and trigeminal somatosensory evoked potentials (TSSEP) allow non-invasive assessment of central sensitisation through analysis of brainstem and cortical excitability. Impaired habituation in nBR and latency shifts in TSSEP have been consistently observed in migraineurs, particularly in those with chronic features.

The nociceptive blink reflex is a trigeminofacial brain-stem reflex which is used in pain research to evaluate the modulation of pain processing. Lack of habituation is a reproducible abnormality found in migraine between attacks, and attains to a model of behavior and a learning process that seem to predispose to attack occurrence. There is strong evidence that lack of habituation during stimulus repetition, despite an initial normal or low response amplitude, is a functional, probably genetically determined, hallmark of the migrainous brain between attacks.

In addition, incapacity to progressively reduce pain-related responses under repetitive stimulation. may favor mechanisms of central sensitization.

03

Conditions studied

  • Chronic Migraine

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence of cardiopulmonary, psychiatric, or neurological comorbidities.
  • Current use of sedatives, opioids, or CGRP-targeting therapies.
  • Pregnancy or breastfeeding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (estimated)

Study arms

  • Active comparator
    Group A (Nebulized dexmedetomidine ):

    About 73 cases suffering from Chronic Migraine will undergo Nebulized dexmedetomidine (1 mcg/kg in 4 mL normal saline) Administered via jet nebulizer for 3 sessions per week for 2weeks

    Drug: Dexmedetomidine

  • Placebo comparator
    Group B (Placebo):

    About 73 cases suffering from Chronic Migraine will undergo Nebulized 4 mL normal saline Administered via jet nebulizer for 3 sessions per week for 2weeks

    Drug: Dexmedetomidine

Interventions

  • Assessment the effect of nebulized dexmedetomidine on central Sensitization and Chronification in patients with episodic or early chronic migraine by using CGRP serum levels and trigeminal neurophysiological biomarkers (nociceptive blink reflex (nBR) and trigeminal somatosensory evoked potentials (TSSEP)).

    Also known as: CGRP serum levels and trigeminal neurophysiological biomarkers

06

What researchers measure

Primary outcomes

  1. Treatment of Chronic Migraine

    Assessment of the patients whom suffering from Chronic Migraine treated by Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine

    Time frame: 6 Months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 6 months is below that.

Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Mar 10, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07769255
Responsible party
Ibthal Osama Fathy Ibrahim (Assistant lecturer at Anesthesiology, surgical intensive care, and pain managemen Departmentt, Beni-Suef University) — Principal investigator
First posted
Aug 17, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 10, 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Ibthal Osama Fathy Ibrahim, MSc
Contact
Ibthal21@gmail.com
+201098273360
Wael Fathy Hassan, Professor
Contact
drwaelfathy@med.bsu.edu.eg
+201006527133
Hatem ElMoutaz Mahmoud, M.D
study chair · Professor of Anesthesiology, Surgical Intensive Care and Pain Management,Faculty of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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