NCT07645833Not yet recruitingPhase 3
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre Trial
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Rigmor Højland Jensen
- Diseases
- High blood pressure
- NCT number
- NCT07645833
- EU CT number
- 2025-524822-16-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 96
- From Jun 2026 to the primary completion date, Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Non-compliance with headache diary completion during screening, defined as less than 80% of the days reported
- Pregnancy, breastfeeding, or planning pregnancy during the sudy period
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.