Effect of Nebulized Dexmedetomidine on Central Sensitization and Chronification in Migraine
ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeni-Suef University
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of cardiopulmonary, psychiatric, or neurological comorbidities.
Current use of sedatives, opioids, or CGRP-targeting therapies.
Pregnancy or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugAssessment 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)).
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Group A (Nebulized dexmedetomidine ):Active comparator 1 intervention
Group B: Group B (Placebo):Placebo comparator 1 intervention
Trial outcomes
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 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov