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NCT Number: NCT07645833

Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

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.

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Key information

Conditions

Idiopathic Intracranial Hypertension (IIH) Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Pseudotumor Cerebri

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eptinezumab

Drug

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

Placebo

Drug

Matching placebo (0.9% saline solution) administered intravenously

Primary outcomes

  1. Mean monthly-to-severe headache days

    Time frame: Weeks 1 to 12

    Mean monthly number of moderate-to-severe headache days, defined as any day with headache of moderate or severe intensity or requiring acute headache medication, assessed using daily diary recordings

Study contacts

Contact information is provided by the study sponsor or research team.

Frederik P.T. Jantzen, Md.

CONTACT

[email protected]

+4538633555

Sponsors and collaborators

Lead sponsor

Rigmor Højland Jensen

Other

Collaborators

  • H. Lundbeck A/S
  • Odense University Hospital

Registry information

Official study 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

Acronym: PRIMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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