Idiopathic Intracranial Hypertension (IIH)Phase 3PRIMANCT07645833
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
A Phase 3 study testing Eptinezumab in people with Idiopathic Intracranial Hypertension (IIH), run by Rigmor Højland Jensen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre 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:
Read more
- 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.
- Being tested
- Eptinezumab, Placebo
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
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
PlaceboDrug
Matching placebo (0.9% saline solution) administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab | Experimental | Participants will receive eptinezumab 300 mg administered intravenously during the double-blind treatment period Receives: Drug: Eptinezumab |
| Placebo | Placebo comparator | Participants will receive matching placebo (0,9% saline) administered intravenously during the double-blind period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Weeks 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigmor Højland Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, Odense University Hospital
- Responsible party
- Sponsor-investigator, Rigmor Højland Jensen, Danish Headache Center
- Investigators
- Rigmor H Jensen, Ass.Professor, Dr.Med., Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645833
- Sponsor's protocol ID
- PRIMA-1
- Other IDs
- 2025-524822-16-00, 2025
- Acronym
- PRIMA
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing of individual participant data has not yet been made. Any future sharing of de-identified data will be subject to applicable data protection regulations, ethical approvals, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT07645833
- Acronym / sponsor ID
- PRIMA / PRIMA-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rigmor Højland JensenUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, Odense University Hospital
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab | Experimental | Drug: EptinezumabParticipants will receive eptinezumab 300 mg administered intravenously during the double-blind treatment period |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo (0,9% saline) administered intravenously during the double-blind period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EptinezumabEptinezumab 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 | Eptinezumab |
| PlaceboMatching placebo (0.9% saline solution) administered intravenously | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing of individual participant data has not yet been made. Any future sharing of de-identified data will be subject to applicable data protection regulations, ethical approvals, and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rigmor H Jensen, Ass.Professor, Dr.Med. principal investigator
Danish Headache Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptinezumab in people with Idiopathic Intracranial Hypertension (IIH), run by Rigmor Højland Jensen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik P.T. Jantzen, Md. (+4538633555, frederik.peter.thal.jantzen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean monthly-to-severe headache days (time frame: Weeks 1 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.