Effect of Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine
1 other identifier
interventional
146
1 country
1
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2026
CompletedFirst Posted
Study publicly available on registry
August 17, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 10, 2027
August 17, 2026
July 1, 2026
6 months
August 12, 2026
August 12, 2026
Conditions
Outcome Measures
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
6 Months
Study Arms (2)
Group A (Nebulized dexmedetomidine ):
ACTIVE COMPARATORAbout 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 COMPARATORAbout 73 cases suffering from Chronic Migraine will undergo Nebulized 4 mL normal saline Administered via jet nebulizer for 3 sessions per week for 2weeks
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)).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence of cardiopulmonary, psychiatric, or neurological comorbidities.
- Current use of sedatives, opioids, or CGRP-targeting therapies.
- Pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beni-Suef University Hospital
Banī Suwayf, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hatem ElMoutaz Mahmoud, M.D
Professor of Anesthesiology, Surgical Intensive Care and Pain Management,Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer at Anesthesiology, surgical intensive care, and pain managemen Departmentt
Study Record Dates
First Submitted
August 12, 2026
First Posted
August 17, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 10, 2027
Last Updated
August 17, 2026
Record last verified: 2026-07