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NCT Number: NCT06974617

Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Amany M Abo Taleb, MD

PRINCIPAL_INVESTIGATOR

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Mohammed S ElSharkawy, MD

PRINCIPAL_INVESTIGATOR

Samuel F Samy, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.

Exclusion criteria

  • Patients with medication over use headache.
  • Bleeding disorders.
  • Abnormal neurological examination.
  • History of allergy to local anesthetics or BOTOX.

Treatment and study plan

Sphenopalatine block

Drug

Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.

Other names: Lidocaine

Botulinum Toxin Type A

Drug

Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Primary outcomes

  1. Degree of pain

    Time frame: 12 weeks post-procedure

    The patients will be shown how to use the Visual Analogue Scale (VAS); 0-10 point where 0 = no pain and 10 = worst imaginable pain. VAS will be noted as well as after procedure, four-week, and 12-weeks period.

Secondary outcomes

  1. Percentage of patients free of headache

    Time frame: 12 weeks post-procedure

    The percentage of patients free of headache at baseline (just before the procedure), after procedure, four-week, and 12-weeks period.

  2. Headache relief rate

    Time frame: 12 weeks post-procedure

    Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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