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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524822-16-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
| Odense University Hospital | OTHER |
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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:
Researchers will compare eptinezumab to placebo to determine whether eptinezumab is effective in the prevention of chronic headache in patients with IIH.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab | Experimental | Participants will receive eptinezumab 300 mg administered intravenously during the double-blind treatment period |
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| Placebo | Placebo Comparator | Participants will receive matching placebo (0,9% saline) administered intravenously during the double-blind period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 1 to 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik P.T. Jantzen, Md. | Contact | +4538633555 | frederik.peter.thal.jantzen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Rigmor H Jensen, Ass.Professor, Dr.Med. | Danish Headache Center | Principal Investigator |
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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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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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| Placebo | Drug | Matching placebo (0.9% saline solution) administered intravenously |
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