Ended Therapeutic use (Phase IV) Chronic Migrane, Migrane, Medication Overuse Headache

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

EU CTIS ID: 2024-510729-24-00

What this study is testing

To evaluate the efficacy of Eptinezumab as add-on to BI for the prevention of migrane and treatment of MOH

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
  • The patient overuses drugs that can be taken for acute treatment of headache during the screening period, based on prospectively collected information in the eDiary.
  • The patient has a history of treatment failure with at least 1 preventive treatment within the last 5 years prior to the Screening Visit.
  • The patient is aged 2:18 and S.75 years at the Screening Visit.C97
  • The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
  • The patient has had an onset of migraine diagnosis at ≤50 years of age.

You likely can't join if

  • The patient has a history of treatment failure with a previous preventive treatment targeting the CGRP pathway including gepants for acute or preventive use within the last 5 years prior to the Screening Visit.
  • The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).C103
  • The patient has a diagnosis of acute or active temporomandibular disorders.
  • The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
  • The patient has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
  • The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
See the full eligibility criteria
Who can join
  • The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
  • The patient overuses drugs that can be taken for acute treatment of headache during the screening period, based on prospectively collected information in the eDiary.
  • The patient has a history of treatment failure with at least 1 preventive treatment within the last 5 years prior to the Screening Visit.
  • The patient is aged 2:18 and S.75 years at the Screening Visit.C97
  • The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
  • The patient has had an onset of migraine diagnosis at ≤50 years of age.
  • The patient has a history of migraine onset of at least 12 months prior to the Screening Visit.
  • The patient has 2:8 migraine days per month for each month within the past 3 months prior to the Screening Visit
  • The patient has a diagnosis of MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.D92
  • The patient has 2:15 headache days per month for each month within the past 3 months prior to the Screening Visit.
  • The patient has regular overuse of one or more drugs that can be taken for acute treatment of headache, for >3 months prior to the Screening Visit.
  • The patient has 2:15 headache days, of which 2:8 days were assessed as migraine days during the screening period, based on prospectively collected information in the eDiary.
What rules you out
  • The patient has a history of treatment failure with a previous preventive treatment targeting the CGRP pathway including gepants for acute or preventive use within the last 5 years prior to the Screening Visit.
  • The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).C103
  • The patient has a diagnosis of acute or active temporomandibular disorders.
  • The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
  • The patient has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
  • The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Australia
  • Georgia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Australia; Georgia. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.