Chronic Migraine HeadacheNCT07535723
Botulinum Toxin and/or Greater Occipital Nerve Block for Patients With Chronic Migraine
A study testing OnabotulinumtoxinA and Greater Occipital Nerve Block (GONB) in people with Chronic Migraine Headache and OnabotulinumtoxinA, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache, OnabotulinumtoxinA, Greater Occipital Nerve Block
- What is being tested?
- OnabotulinumtoxinA and Greater Occipital Nerve Block (GONB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Beni-Suef University Hospital
Al Fayyum
01010897786, rakiamohamed697@gmail.com
About this study
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.
Read the 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
- Being tested
- OnabotulinumtoxinA, Greater Occipital Nerve Block (GONB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
Greater Occipital Nerve Block (GONB)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BoNT-A + GONB | Experimental | Not described Receives: 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. Receives: 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. Receives: Procedure: Greater Occipital Nerve Block (GONB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month and 3 months after treatment
Secondary outcomes (8)
Time to achieve ≥30% reduction in monthly migraine days (MMD)
Time from treatment initiation to the first occurrence of a ≥30% reduction in monthly migraine days compared to baseline
Measured: Up to 3 months after treatment
Change in Headache Impact Test (HIT-6) score
Change from baseline in Headache Impact Test (HIT-6) total score (range: 36-78), where higher scores indicate greater headache-related disability and worse outcomes
Measured: Baseline, 1 month, and 3 months after treatment
Change in Allodynia Symptom Checklist (ASC-12) score
Change from baseline in Allodynia Symptom Checklist (ASC-12) total score (range: 0-24), where higher scores indicate more severe cutaneous allodynia
Measured: Baseline, 1 month, and 3 months after treatment
Change in Migraine Interictal Burden Scale (MIBS-4) score
Change from baseline in Migraine Interictal Burden Scale (MIBS-4) total score (range: 0-12), where higher scores indicate greater interictal burden
Measured: Baseline, 1 month, and 3 months after treatment
Change in acute migraine medication use
Change from baseline in the frequency of acute migraine medication use as recorded in patient diaries
Measured: Baseline, 1 month, and 3 months after treatment
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) measured using a 7-point Likert scale (range: 1-7), where higher scores indicate greater improvement
Measured: 1 month and 3 months after treatment
Short Assessment of Patient Satisfaction (SAPS) score
Patient satisfaction measured using the Short Assessment of Patient Satisfaction (SAPS) total score (range: 0-28), where higher scores indicate greater patient satisfaction
Measured: 1 month and 3 months after treatment
Incidence of adverse events
Number and severity of treatment-related adverse events (local and systemic)
Measured: Up to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Rakia Mohamed Taha Basiouny, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535723
- Sponsor's protocol ID
- RakiaBasiouny97$
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39801092Inan 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.
PubMed 30612462Ashkenazi 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.
PubMed 17682008Ashkenazi 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.
PubMed 17504651
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin and/or Greater Occipital Nerve Block for Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT07535723
- Acronym / sponsor ID
- RakiaBasiouny97$
- Conditions
- Chronic Migraine Headache, OnabotulinumtoxinA, Greater Occipital Nerve Block, Combination Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BoNT-A + GONB | Experimental | Drug: OnabotulinumtoxinA, Procedure: Greater Occipital Nerve Block (GONB) |
| Arm 2: BoNT-A alone | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites. |
| Arm 3: GONB alone | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAOnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites. | Drug | Arm 1: BoNT-A + GONB, Arm 2: BoNT-A alone |
| 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 | Procedure or surgery | Arm 1: BoNT-A + GONB, Arm 3: GONB alone |
Primary outcome
Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD)
Time frame: 1 month and 3 months after treatment
Responder rate defined as the proportion of participants achieving a ≥50% reduction in monthly migraine days compared to baseline, as recorded in headache diaries
8 secondary outcomes
Time to achieve ≥30% reduction in monthly migraine days (MMD)
Time frame: Up to 3 months after treatment
Change in Headache Impact Test (HIT-6) score
Time frame: Baseline, 1 month, and 3 months after treatment
Change in Allodynia Symptom Checklist (ASC-12) score
Time frame: Baseline, 1 month, and 3 months after treatment
Change in Migraine Interictal Burden Scale (MIBS-4) score
Time frame: Baseline, 1 month, and 3 months after treatment
Change in acute migraine medication use
Time frame: Baseline, 1 month, and 3 months after treatment
Patient Global Impression of Change (PGIC)
Time frame: 1 month and 3 months after treatment
Short Assessment of Patient Satisfaction (SAPS) score
Time frame: 1 month and 3 months after treatment
Incidence of adverse events
Time frame: Up to 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 39801092Arata 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.
- Results publication: PubMed 30612462Inan 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.
- Results publication: PubMed 17682008Ashkenazi 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.
- Results publication: PubMed 17504651Ashkenazi 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OnabotulinumtoxinA and Greater Occipital Nerve Block (GONB) in people with Chronic Migraine Headache and OnabotulinumtoxinA, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakia Mohamed Basiouny, neurology resident (+201010897786, rakiamohamed697@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD) (time frame: 1 month and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535723, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.