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Can a No-Fridge migraine shot replace botox?

NCT ID NCT05598723

Disease control Sponsor: Naval Medical Center Camp Lejeune Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether incobotulinumtoxinA (Xeomin), a botulinum toxin that does not require refrigeration, works as well as onabotulinumtoxinA (Botox) for preventing chronic migraine. Adults with 15 or more headache days per month will receive injections of either drug at two time points. The study aims to find a more portable alternative to Botox for people who need migraine prevention but lack access to cold storage.

What this could mean

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

Active substance
botulinum toxin type A (either onabotulinumtoxinA or incobotulinumtoxinA)
What this could lead to
If Xeomin works as well as Botox, it could offer a more portable treatment option for chronic migraine, especially for military personnel in remote settings.
What could go wrong
This is a relatively small trial, and Xeomin is not yet FDA-approved for migraine. It may prove less effective or have different side effects than Botox.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 128 people

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

Started

Feb 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 89 years

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: * Between ages of 18-89 * 15 or more headaches days experienced per month lasting 4 hours or longer * Department of Defense (DoD) Beneficiary/TriCare Eligible * Failure, contraindication or intolerance to two migraine medications from two different classes. * Able to provide informed consent and be able to read and write English. * Able to read, comprehend, and complete the assessment and diary * Women must provide a negative urine pregnancy test Exclusion Criteria: * Currently pregnant, breastfeeding, or planning to become pregnant * Allergic to botulinum toxin or to any of the ingredients of the medication * Has myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, any temporomandibular disfunction, or any other significant disease that might interfere with neuromuscular function. * Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit * Those on oral anticoagulation * Previous botulinum toxin treatment on the cephalic/upper lumbar region within 6 months for any indication * Localized infections on face, neck or on antibiotics for areas in this region * Unable to attend study follow up visits for any reason (i.e. Training, deployment, or PCS) * Use of any prophylactic headache medication between -4 weeks and week 0 visits * Any person taking chronic pain medication for a chronic indication * Any diagnosed psychiatric condition which would prohibit a participant from completing the trial in its totality.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Chronic migraine

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

  • Naval Medical Center Camp Lejeune

    RECRUITING

    Jacksonville, North Carolina, 28547, United States

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