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| Name | Class |
|---|---|
| Cairo University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BoNT-A + GONB | Experimental |
| |
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 months after treatment |
| Change in Headache Impact Test (HIT-6) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rakia Mohamed Basiouny, neurology resident | Contact | +201010897786 | rakiamohamed697@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University Hospital | Al Fayyum | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39801092 | Result | 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. | |
| 30612462 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2026 | Apr 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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.
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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.
| 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 |
|
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 |
| 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 | 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 | 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 | 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 | 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 | 1 month and 3 months after treatment |
| Incidence of adverse events | Number and severity of treatment-related adverse events (local and systemic) | Up to 3 months after treatment |
| 17682008 | 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. |
| 17504651 | 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. |
| Related Info | View source |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |