MedTrace Logo

Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

NCT07645833 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-06-12

No results posted yet for this study

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)

Interventions

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

DRUG

Placebo

Matching placebo (0.9% saline solution) administered intravenously

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Odense University Hospital

    collaborator OTHER

  • Rigmor Højland Jensen

    lead OTHER

Principal Investigators

  • Rigmor H Jensen, Ass.Professor, Dr.Med. · Danish Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2028-06-30
Completion
2029-01-31

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645833 on ClinicalTrials.gov