NCT07535723

Botulinum Toxin and/or Greater Occipital Nerve Block for Patients With Chronic Migraine

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic migraine is a debilitating neurological disorder that significantly affects patients' daily functioning, mental health, and quality of life. Management typically includes acute and preventive treatments, but effectiveness can be limited due to medication overuse or delayed onset of action. OnabotulinumtoxinA injections provide proven long-term preventive benefits, while Greater Occipital Nerve (GON) block offers rapid but short-term relief. Although both treatments are used individually, evidence on the combined effect is limited. This randomized controlled trial aims to evaluate the efficacy and safety of combining OnabotulinumtoxinA injections with GON block, assessing improvements in headache frequency, severity, and patient quality of life compared to single therapy.

Detailed description

Chronic migraine is a disabling neurological disorder that affects a significant proportion of the population, leading to substantial functional, psychological, and economic burdens. Despite the availability of acute and preventive treatments, many patients continue to experience frequent headaches due to limited efficacy, delayed onset of action, or medication overuse. OnabotulinumtoxinA injections have been shown to provide sustained preventive benefits in chronic migraine, reducing headache frequency and improving patient quality of life. Greater Occipital Nerve (GON) block offers rapid relief of headache symptoms, though the effect is typically short-term. While both interventions are used individually, there is limited evidence on the benefits of combining them to achieve both immediate and sustained symptom control. This randomized controlled trial aims to evaluate the safety and efficacy of combining OnabotulinumtoxinA injections with GON block in adult patients with chronic migraine. Participants will be randomly assigned to one of the following groups: OnabotulinumtoxinA alone, GON block alone, combined therapy, or standard care. Headache frequency, severity, duration, and patient-reported quality of life will be assessed over a 12-week follow-up period. Adverse events and tolerability will also be recorded systematically. The study is conducted under the supervision of an independent ethics committee to ensure participant safety and adherence to Good Clinical Practice standards. Findings from this study aim to provide evidence on whether an integrated therapeutic approach can offer superior relief and improve long-term outcomes for patients with chronic migraine.

Conditions

• Chronic Migraine Headache
• OnabotulinumtoxinA
• Greater Occipital Nerve Block
• Combination Therapy

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
PROCEDURE	Greater Occipital Nerve Block (GONB)	Injection of local anesthetic (2% lidocaine, 1-2 mL per side) around the greater occipital nerve at the occipital region. Procedure performed by trained neurologist

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Egypt