Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

NCT07645833 | Not Yet Recruiting Phase 3

• 2 other identifiers: PRIMA-12025-524822-16-00
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Eptinezumab

EXPERIMENTAL

Participants will receive eptinezumab 300 mg administered intravenously during the double-blind treatment period

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo (0,9% saline) administered intravenously during the double-blind period

Drug: Placebo

Interventions

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

Eptinezumab

Placebo DRUG

Matching placebo (0.9% saline solution) administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigmor Højland Jensen: lead
• H. Lundbeck A/S: collaborator
• Odense University Hospital: collaborator

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rigmor H Jensen, Ass.Professor, Dr.Med.

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik P.T. Jantzen, Md.

CONTACT

+4538633555; frederik.peter.thal.jantzen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass.Professor, Dr. Med., Principal Investigator and Sponsor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06