New hope for IIH headache sufferers: migraine drug tested in landmark trial
NCT ID NCT07645833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether eptinezumab, a drug used for migraines, can reduce the number of headache days in adults with idiopathic intracranial hypertension (IIH), a condition where high fluid pressure around the brain causes severe headaches. About 96 women aged 18-55 with chronic headaches will receive either the drug or a placebo. The goal is to see if the drug lowers monthly moderate-to-severe headache days and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female, aged 18 to 55 years * Diagnosis of idiopathic intracranial hypertension (IIH) or IIH without papilledema * Chronic headache associated with IIH * At least 15 headache days per monthduring the screening period * At least 8 migraine-like headache days per month during the screening period * Use of effective contraception througout the trial period and for at least 5 months after last administration of study drug Exclusion Criteria: * Non-compliance with headache diary completion during screening, defined as less than 80% of the days reported * Contraindications to receiving eptinezumab according to the Summary of Product Characteristics * Previous or current treatment with anti-CGRP monoclonal antibodies within 5 half-lives * Previous insufficient or non-effective treatment with eptinezumab * Pregnancy, breastfeeding, or planning pregnancy during the sudy period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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