Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorRigmor Højland Jensen

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

96 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Rigmor Højland Jensen

Lead sponsor

Danish Headache Center

Sponsor institution

H. Lundbeck A/S

Collaborator

Odense University Hospital

Collaborator