Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Last updated: May 15, 2025
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Migraine And Cluster Headaches

Migraine (Pediatric)

Treatment

Sphenopalatine block

Botulinum Toxin Type A

Clinical Study ID

NCT06974617
AP2411-501-101-193
  • Ages 18-65
  • All Genders

Study Summary

This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 and 65 years.

  • Both sexes.

  • Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond tomigraine-specific treatment according to International Classification of HeadacheDisorders-3 Beta.

Exclusion

Exclusion Criteria:

  • Patients with medication over use headache.

  • Bleeding disorders.

  • Abnormal neurological examination.

  • History of allergy to local anesthetics or BOTOX.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Sphenopalatine block
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
October 01, 2025

Study Description

The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.

Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.

The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release

Connect with a study center

  • Cairo University

    Cairo, 12613
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.