Chronic MigraineNCT07769255
Effect of Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine
A study testing Dexmedetomidine in people with Chronic Migraine, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 10 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Presence of cardiopulmonary, psychiatric, or neurological comorbidities.
- Current use of sedatives, opioids, or CGRP-targeting therapies.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf
Dina Mahmoud Fakhry, Lecturer, +201289998680, Drdina.mahmoud@med.bsu.edu.eg
Reem Mohammed Sabry, Lecturer, +201122160532, Doctor_neurophysiology@med.bsu.edu.eg
About this study
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
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.
- Conditions
- Chronic Migraine
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called CGRP serum levels and trigeminal neurophysiological biomarkers
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)).
| Study group | Role | What they receive |
|---|---|---|
| Group A (Nebulized dexmedetomidine ): | Active comparator | 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 Receives: Drug: Dexmedetomidine |
| Group B (Placebo): | Placebo comparator | 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 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Chronic Migraine
Assessment of the patients whom suffering from Chronic Migraine treated by Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibthal Osama Fathy Ibrahim, Beni-Suef University
- Investigators
- Hatem ElMoutaz Mahmoud, M.D, Study chair, Professor of Anesthesiology, Surgical Intensive Care and Pain Management,Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769255
- Sponsor's protocol ID
- Chronification in Migraine
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07769255
- Acronym / sponsor ID
- Chronification in Migraine
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Nebulized dexmedetomidine ): | Active comparator | Drug: DexmedetomidineAbout 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 |
| Group B (Placebo): | Placebo comparator | Drug: DexmedetomidineAbout 73 cases suffering from Chronic Migraine will undergo Nebulized 4 mL normal saline Administered via jet nebulizer for 3 sessions per week for 2weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of cardiopulmonary, psychiatric, or neurological comorbidities.
- Current use of sedatives, opioids, or CGRP-targeting therapies.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: CGRP serum levels and trigeminal neurophysiological biomarkersAssessment 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)). | Drug | Group A (Nebulized dexmedetomidine ):, Group B (Placebo): |
Primary outcome
Treatment of Chronic Migraine
Time frame: 6 Months
Assessment of the patients whom suffering from Chronic Migraine treated by Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem ElMoutaz Mahmoud, M.D study chair
Professor of Anesthesiology, Surgical Intensive Care and Pain Management,Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Chronic Migraine, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibthal Osama Fathy Ibrahim, MSc (+201098273360, Ibthal21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Chronic Migraine (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.