About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Eptinezumab
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Rigmor Højland Jensen
Lead sponsor
Danish Headache Center
Sponsor institution
H. Lundbeck A/S
Collaborator
Odense University Hospital
Collaborator