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

NCT07535723 | Not Yet Recruiting

• 1 other identifier: RakiaBasiouny97$
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD)

  Responder rate defined as the proportion of participants achieving a ≥50% reduction in monthly migraine days compared to baseline, as recorded in headache diaries

  1 month and 3 months after treatment

Secondary Outcomes (8)

• Time to achieve ≥30% reduction in monthly migraine days (MMD)

  Up to 3 months after treatment

• Change in Headache Impact Test (HIT-6) score

  Baseline, 1 month, and 3 months after treatment

• Change in Allodynia Symptom Checklist (ASC-12) score

  Baseline, 1 month, and 3 months after treatment

• Change in Migraine Interictal Burden Scale (MIBS-4) score

  Baseline, 1 month, and 3 months after treatment

• Change in acute migraine medication use

  Baseline, 1 month, and 3 months after treatment

Study Arms (3)

Arm 1: BoNT-A + GONB

EXPERIMENTAL

Drug: OnabotulinumtoxinA; Procedure: Greater Occipital Nerve Block (GONB)

Arm 2: BoNT-A alone

EXPERIMENTAL

OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.

Drug: OnabotulinumtoxinA

Arm 3: GONB alone

EXPERIMENTAL

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.

Procedure: Greater Occipital Nerve Block (GONB)

Interventions

OnabotulinumtoxinA DRUG

OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.

Arm 1: BoNT-A + GONB; Arm 2: BoNT-A alone

Greater Occipital Nerve Block (GONB) PROCEDURE

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

Arm 1: BoNT-A + GONB; Arm 3: GONB alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3): headache occurring on ≥15 days per month for more than three months, with at least 8 days per month exhibiting migraine features. (International Headache Society, 2013)
• Age \> 18 years
• Stable preventive migraine regimen for at least two months prior to recruitment

You may not qualify if:

• Co-morbid other
• Prior treatment with BoNT-A or GONB for headache within the previous 3 months.
• Known hypersensitivity to BoNT-A or local anesthetics.
• Cervical anatomical abnormalities that hinder proper localization of injection sites or compromise the safety of the procedure
• Neuromuscular junction disorders (e.g., myasthenia gravis).
• Coagulation disorders or anticoagulant therapy that contraindicates nerve block.
• Significant psychiatric comorbidity that would impair proper pre and post treatment assessment.
• Pregnancy.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (1)

Beni-Suef University Hospital

Al Fayyum, Egypt

Location

Related Publications (4)

• Arata WH, Midha RK, Varrassi G, Sala K, Plessala MJ, Brodtmann J, Dufrene K, Palowsky Z, Griffin P, Ahmadzadeh S, Shekoohi S, Kaye AD. Occipital nerve block for headaches: a narrative review. J Oral Facial Pain Headache. 2024 Jun;38(2):1-10. doi: 10.22514/jofph.2024.010. Epub 2024 Jun 12.

  PMID: 39801092 RESULT

• Inan LE, Inan N, Unal-Artik HA, Atac C, Babaoglu G. Greater occipital nerve block in migraine prophylaxis: Narrative review. Cephalalgia. 2019 Jun;39(7):908-920. doi: 10.1177/0333102418821669. Epub 2019 Jan 6.

  PMID: 30612462 RESULT

• Ashkenazi A, Matro R, Shaw JW, Abbas MA, Silberstein SD. Greater occipital nerve block using local anaesthetics alone or with triamcinolone for transformed migraine: a randomised comparative study. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):415-7. doi: 10.1136/jnnp.2007.124420. Epub 2007 Aug 6.

  PMID: 17682008 RESULT

• Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep. 2007 Jun;11(3):231-5. doi: 10.1007/s11916-007-0195-3.

  PMID: 17504651 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Rakia Mohamed Basiouny, neurology resident

CONTACT

+201010897786; rakiamohamed697@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: randomized, assessor-blinded, controlled trial will include 90 patients diagnosed with chronic migraine. Participants will be randomly assigned to one of three treatment groups: Group 1 (n = 30) will receive BoNT A combined with GONB; Group 2 (n=30) will receive BoNT-A alone; and Group 3 (n = 30) will receive a GONB alone. Randomization will be performed using a computer-generated allocation sequence. Block randomization will be employed to ensure balanced allocation across the groups throughout the enrollment period. Randomization sequence will be generated by an independent investigator who is not involved in participant recruitment, clinical evaluation, intervention administration, or data analysis. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE), This procedure minimizes selection bias and preserves the integrity of the randomization process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Resident

Model Details: Participants will be randomly assigned to one of three parallel groups: (1) OnabotulinumtoxinA injections alone, (2) Greater Occipital Nerve (GON) block alone, or (3) combined OnabotulinumtoxinA and GON block. Each group will be followed over a 12-week period to assess changes in headache frequency, severity, duration, and patient-reported quality of life. Adverse events and tolerability will be monitored throughout the study. This design allows direct comparison of single versus combined interventions in patients with chronic migraine.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)