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New migraine combo drug passes early safety check

NCT ID NCT06578585

Symptom relief Sponsor: H. Lundbeck A/S 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study looked at whether it is safe to take the experimental drug Lu AG09222 together with the approved migraine pill ubrogepant. 43 adults with migraine received both treatments or a placebo injection. The main goal was to track any side effects, not to measure how well the drugs work.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

43 people

The number who actually took part.

Started

Sep 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 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: * The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit. * The participant has a history of migraine onset ≥12 months prior to the Screening Visit. * The participant has ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the Screening Visit. * The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit. Exclusion Criteria: * The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment. * The participant has participated in a clinical trial \<30 days prior to the Screening Visit. * The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives of that product, whichever is longer, prior to Visit 1. * The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods. * The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients. Note: Other inclusion and exclusion criteria may apply.

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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.

Migraine

Contacts and locations

Locations

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801, United States

  • Elevate Clinical Research

    Seabrook, Texas, 77586, United States

  • Future Search Trials

    Austin, Texas, 78731, United States

  • NeuroTrials Research

    Atlanta, Georgia, 30328, United States

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