Status
Not yet recruiting
Phase
Phase 3
Enrollment
96
Locations
0
Results
Not posted
Publications
0
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.
Interventions
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
DRUG
Matching placebo (0.9% saline solution) administered intravenously
Timeline
First posted
Jun 12, 2026
Study start
Jun 22, 2026
Primary completion
Jun 2028
Study completion
Jan 2029
Results posted
Not reported
Registry updated
Jun 12, 2026
Outcomes
Mean monthly-to-severe headache days
Time frame · 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
Not reported in the indexed record.
Eligibility
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 locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Migraine · Headache
Not applicable
Completed
513
2026-07
Jordan University of Science and Technology · Root Canal Treatment · Postoperative Pain
Not applicable
Active, not recruiting
75
2026-07
Tanta University · Calcitonin · Subcutaneous
Phase 3
Recruiting
168
2026-07
Insel Gruppe AG, University Hospital Bern · Acute Mountain Sickness
Phase 4
Not yet recruiting
30
2026-07
Institut Claudius Regaud · Medullary Thyroid Cancer
Not applicable
Completed
24
2026-06
IRCCS San Raffaele Roma · Episodic Migraine · Chronic Migraine
Not applicable
Recruiting
2,641
2026-06
Pamukkale University · Neck Pain · Text Neck Syndrome
Not applicable
Completed
38
2026-05
Jonsson Comprehensive Cancer Center · Thyroid Gland Medullary Carcinoma
Not applicable
Not yet recruiting
100
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.