A Phase 4 interventional study of OnabotulinumtoxinA and Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve in Chronic Migraine, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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Among 39 studies testing botulinum toxin type A in Migraine Disorders — 6 open to participants now, 10 under way, 5 of them phase 3. botulinum toxin type A · Migraine Disorders.
Among the 39 studies testing botulinum toxin type A in Migraine Disorders, this one is the 19th largest by planned enrollment, is one of 3 that started in 2026, is one of 12 in phase 4, and was the 39th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →6 of the 39 studies testing botulinum toxin type A in Migraine Disorders are open now, in 2 countries. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 18–65
Naval Medical Center Camp Lejeune · Sites in United States
Ages 18–89
Assiut University
Ages 18–65
Beni-Suef University · Sites in Egypt
Ages 18+
Europainclinics z.ú.
Ages 18–80
By country, each count listing its studies:
botulinum toxin type A: first FDA approval 1991 (BOTOX COSMETIC), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 14 · Phase 4 12
First in 2003; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 70 across the 39 interventional studies. Of the 25 that completed or were terminated, 17 (68%) have results posted.
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20 of 39 have an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
11 studies in Migraine Disorders by Assiut University: 8 open now, 8 under way, none of them phase 3.
Among the 11 studies in Migraine Disorders by Assiut University, this one is one of 4 that started in 2026, is one of 3 in phase 4, and was the 11th registered.
Assiut University’s Migraine Disorders studies by the year they started, since 2020.
4 of the studies testing botulinum toxin type A in Migraine Disorders that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05598723Phase 3Naval Medical Center Camp LejeuneBOTOX® vs. XEOMIN® for Chronic Migraine | 2027-02-24 |
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
| NCT07837570Assiut UniversityComparison of the Effectiveness of Greater Occipital Nerve and Supratrochlear Nerve Pulsed Radiofrequency Versus Botulinum Toxin Type A Injection in Chronic Migraine | 2027-10 |
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Among the 39 studies testing botulinum toxin type A in Migraine Disorders, from their registry updates:
Among Assiut University’s 11 in Migraine Disorders:
Nothing recorded among them since 2026-09-25.
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Migraine is a common chronic neurovascular disorder ranked among the leading causes of disability worldwide, and its global burden has continued to rise over the past three decades, with prevalence increasing substantially between 1990 and 2021the global number of prevalent cases, incident cases, and DALYs for migraine increased by 58%, 42%, and 58% respectively from 1990 to 2021 (1). In 2021, migraine affected an estimated 1.2 billion people globally, and although tension-type headache was more prevalent, migraine caused greater disability (2). Chronic migraine, defined as headache occurring on 15 or more days per month for more than three months, with migrainous features on at least 8 days, represents a particularly disabling subtype that is frequently refractory to standard pharmacological prophylaxis (3). Pharmacologic treatment of chronic migraine often has limited efficacy, prompting growing interest in interventional and peripheral neuromodulatory approaches (4).
OnabotulinumtoxinA is currently the only FDA-approved interventional prophylactic therapy for chronic migraine, with efficacy established by class-one evidence from the PREEMPT clinical program (5). Although onabotulinumtoxinA is traditionally known for inhibiting muscle contraction, its efficacy in chronic migraine is now attributed to inhibition of SNARE-mediated vesicle trafficking in sensory as well as motor nerve terminals (6). However, treatment with onabotulinumtoxinA, while effective, must be repeated every three months for sustained relief and can impose a significant financial burden on patients (7), which has driven exploration of alternative peripheral procedures targeting the same pericranial sensory nerve distribution.
Greater occipital nerve block and PRF have shown efficacy in reducing migraine frequency, intensity, and duration, with pulsed radiofrequency treatment thought to reduce conduction in nociceptive fibers through a neuromodulatory, non-neurodestructive mechanism (8). Randomized data comparing GON block with GON-PRF found that VAS pain scores were significantly lower in the PRF group than the GON block group at six months follow-up (9), and longer-term cohort data have shown durable benefit of GON-targeted radiofrequency techniques over twelve months of follow-up (10). Beyond the occipital nerve, radiofrequency ablation of pericranial nerves including the supratrochlear and supraorbital nerves has emerged as a promising option for headache conditions refractory to pharmacologic treatment, with a favorable and largely self-limited side-effect profile (7). Case reports have further demonstrated good therapeutic response to PRF in patients whose chronic migraine remained refractory even after botulinum toxin injection.
Despite this growing evidence base, direct head-to-head comparisons between combined GON-supratrochlear nerve PRF and onabotulinumtoxinA injection, the two leading peripheral interventional strategies covering the trigeminal and occipital sensory distribution, remain scarce. Given the cost, repeated dosing requirement, and resource burden associated with botulinum toxin therapy, and the emerging durability data for PRF, a direct comparative study is warranted to determine which modality offers superior and more sustained efficacy, better safety, and greater cost-effectiveness for patients with chronic migraine.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other primary headache disorders (tension-type headache, cluster headache, hemicrania continua) as the predominant headache type.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve
Procedure: Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve
OnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.
Drug: OnabotulinumtoxinA
patients will recive OnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.
patients will recive Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve
Change in the mean number of monthly migraine days
Change in the mean number of monthly migraine days (MMD) from baseline to 12 weeks and 24 weeks post-intervention
Time frame: 24 weeks post-intervention
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 49 non-industry phase 4 interventional studies under Migraine Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 12 months is below that.
Counting every sponsor, half of 77 studies reached it within 27 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A