Idiopathic Intracranial Hypertension (IIH)
Conditions
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.
Interventions
DRUGEptinezumab
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
DRUGPlacebo
Matching placebo (0.9% saline solution) administered intravenously
Sponsors
Rigmor Højland Jensen
H. Lundbeck A/S
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean monthly-to-severe headache days | 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 |
Contacts
CONTACTFrederik P.T. Jantzen, Md.
PRINCIPAL_INVESTIGATORRigmor H Jensen, Ass.Professor, Dr.Med.
Danish Headache Center
Outcome results
None listed