Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension

ConditionIdiopathic Intracranial Hypertension (IIH)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

96 Participants

are divided into 2 treatment groups

Group A: EptinezumabExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Weeks 1 to 12

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigmor Højland Jensen

Lead sponsor

Danish Headache Center

Sponsor institution

H. Lundbeck A/S

Collaborator

Odense University Hospital