Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eptinezumab, Placebo.
- Who it may be relevant to
- Registry conditions: Idiopathic Intracranial Hypertension (IIH). Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Eptinezumab
Eptinezumab 300 mg. administered as an intravenous infusion in 100 ml. saline solution at baseline and at week 12 during the double-blind treatment period. participants may subsequently receive open-label eptinezumab according to the study protocol - Drug Placebo
Matching placebo (0.9% saline solution) administered intravenously
Primary outcome measures
- Mean monthly-to-severe headache days [Time frame: Weeks 1 to 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07645833 · PRIMA-1 · 2025-524822-16-00