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Double attack on migraine: botox plus nerve block shows promise

NCT ID NCT07535723

Symptom relief Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether combining Botox injections with a nerve block at the back of the head works better than either treatment alone for chronic migraine. About 90 adults with frequent migraines will receive one of the treatments or both. The goal is to see if the combination reduces headache days and improves daily life more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OnabotulinumtoxinA (Botox) and local anesthetic (lidocaine) nerve block
What this could lead to
If it works, this could offer a more effective way to reduce migraine days and improve quality of life for people with chronic migraine.
What could go wrong
This is a small, early-stage trial with only 90 participants. The combination may not work better than either treatment alone, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

headache disorder migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine headache Combination therapy Greater occipital nerve block Onabotulinumtoxina

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beni-Suef University Hospital

    Al Fayyum, Egypt

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