Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension (NCT07645833) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
96 participantsStarted 2026-06-22
Plain-language summary
The goal of this clinical trial is to learn if eptinezumab can reduce headache frequency and headache-related disability in adults with idiopathic intracranial hypertension (IIH) and chronic headache. It will also evaluate the safety and tolerability of eptinezumab in this patient population.
The main questions it aims to answer are:
* Does eptinezumab reduce the number of monthly moderate-to-severe headache days compared with placebo?
* Does eptinezumab improve headache-related disability and patient-reported outcomes?
* What adverse events occur during treatment with eptinezumab?
Researchers will compare eptinezumab to placebo to determine whether eptinezumab is effective in the prevention of chronic headache in patients with IIH.
Participants will:
* Receive eptinezumab or placebo according to random assignment.
* Attend scheduled study visits and clinical assessments.
* Complete headache diaries and questionnaires during the study period.
* Undergo study-related examinations and collection of biological samples, including blood samples.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.