Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension (PRIMA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Intracranial Hypertension (IIH)
• Intervention / Treatment: Drug: Eptinezumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Frederik P.T. Jantzen, Md.; Phone Number: +4538633555; Email: frederik.peter.thal.jantzen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eptinezumab; Participants will receive eptinezumab 300 mg administered intravenously during the double-blind treatment period	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
Placebo Comparator: Placebo; Participants will receive matching placebo (0,9% saline) administered intravenously during the double-blind period	Drug: Placebo; Matching placebo (0.9% saline solution) administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean monthly-to-severe headache days	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	Weeks 1 to 12

Collaborators and Investigators

• Sponsor: Rigmor Højland Jensen
• Collaborators: Odense University Hospital; H. Lundbeck A/S
• Investigators: Principal Investigator: Rigmor H Jensen, Ass.Professor, Dr.Med., Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri; eptinezumab
• Other Study ID Numbers: PRIMA-1; 2025-524822-16-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding sharing of individual participant data has not yet been made. Any future sharing of de-identified data will be subject to applicable data protection regulations, ethical approvals, and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No