ClinicalTrials.gg
Not yet recruitingNCT07780136Updated Sep 22, 2026

Effectiveness of Greater Occipital Nerve and Supratrochlear Nerve Pulsed Radiofrequency Versus Botulinum Toxin Type A Injection in Chronic Migraine

A Phase 4 interventional study of Ultrasound-guided pulsed radiofrequency (PRF) and OnabotulinumtoxinA in Chronic Migraine Headache, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

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Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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.

Planned enrollment
19th of 39
70 · median 70
Started
2026
with 2 others
Phase 4
12 of 39
2 open now
Registered
38th of 39
by date
Lead sponsor
2 of 39
Assiut University

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 38th registered.

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Open to participants now

6 of the 39 studies testing botulinum toxin type A in Migraine Disorders are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

About botulinum toxin type A

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 →

Who these studies take

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 →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies testing botulinum toxin type A in Migraine Disorders, or all of them as a file.
02

Study summary

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 (10).

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.

03

Conditions studied

  • Chronic Migraine Headache

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

    • Age between 18 and 65 years, either sex.

      • Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (headache occurring on ≥15 days/month for >3 months, with migrainous features on ≥8 days/month).
      • Inadequate response, intolerance, or to at least one standard oral preventive medication (e.g., amitriptyline, propranolol, topiramate, flunarizine, valproate).
      • Stable dose of any concurrent prophylactic medication for at least 4 weeks prior to enrolment, with no planned change during the study period.
      • Willingness and ability to complete headache diaries and follow-up visits.

Exclusion criteria

Exclusion Criteria:

    • Other primary headache disorders (tension-type headache, cluster headache, hemicrania continua) as the predominant headache type.

      • Secondary headache due to an identifiable structural, infectious, vascular, or neoplastic cause (confirmed or suspected by history/imaging).
      • Prior botulinum toxin injection or radiofrequency procedure for headache within the last 6 months.
      • Known or allergy to botulinum toxin or to local anesthetics.
      • Pregnancy or lactation.
      • Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
      • Medication overuse headache not resolved prior to enrolment.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Group A

    Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve.

    Procedure: Ultrasound-guided pulsed radiofrequency (PRF)

  • Active comparator
    Group B

    OnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.

    Drug: OnabotulinumtoxinA

Interventions

  • ProcedureUltrasound-guided pulsed radiofrequency (PRF)

    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.

06

What researchers measure

Primary outcomes

  1. number of monthly migraine days

    the mean number of monthly migraine days (MMD)

    Time frame: aseline to 12 weeks and 24 weeks post-intervention,

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2026, 0 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 0 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.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2026
CompletionEst.
Dec 2026
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07780136
Lead sponsor
Assiut University
Responsible party
Kamal Eldin Mohamed Ali Ahmed (residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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Studies of the drug tested here: Botulinum toxin type A

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