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A dose-finding trial with LU AG90222 in adults with migraine who have not been helped by prior preventative treatments.
EU CTIS ID: 2023-508821-28-00
What this study is testing
To evaluate the efficacy of Lu AG09222 for the prevention of migraine
- Therapeutic exploratory (Phase II)
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 participant has a diagnosis of migraine as defined by ICHD-3 guidelines (section 1.1 Migraine without Aura, or 1.2.1 Migraine with typical Aura, or 1.3 Chronic Migraine) confirmed at the Screening Visit.
- The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
- The participant has a migraine onset at ≤50 years of age.
- The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- The participant fulfils the following criteria for EM or CM in prospectively collected information in the eDiary during the first 28 days of the Screening Period: o For participants with EM: migraine occurring on ≥4 days and headache occurring on <15 days o For participants with CM: migraine occurring on ≥8 days and headache occurring on ≥15 days and ≤26 days
- The participant has demonstrated compliance with the eDiary by entry of data for ≥24 of the 28 days following the Screening Visit.
You likely can't join if
- The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
- The participant has a diagnosis of acute or active temporomandibular disorder.
- The participant has a history or diagnosis of chronic tension-type headache, cluster headache, headache attributed to trauma or injury to the head and/or neck, paroxysmal hemicrania, short lasting unilateral neuralgiform headache attacks, hemicrania continua, primary thunderclap headache, primary stabbing headache, nummular headache, new daily persistent headache, hypnic headache, trigeminal neuralgia, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness) or aura lasting >60 minutes.
- The following concomitant medications/substances are disallowed or allowed with restrictions (the list is not comprehensive): Disallowed: any investigational products within 30 days or 5 half-lives (whichever is longer) before the Screening Visit; preventive migraine treatments; anti-CGRP treatment; CNS- or migraine-related devices (neuromodulation, neurostimulation) or injectable therapies (such as trigger-point injections, extracranial nerve blocks, or facet joint injections); botulinum toxin; or monoamine oxidase inhibitors, ketamine, methysergide, methylergonovine, or nimesulide; immunosuppressants (for example, systemic steroids). Allowed with restriction: acute treatment of migraine (prescription or OTC medication), amphetamines, anti-impotence agents; barbiturates (including Fiorinal, Fioricet, or any other combination containing butalbital); opiates (including single-ingredient or combination medications containing opiates, opioids, tramadol, or tapentadol); cannabinoids; benzodiazepines; inhalation steroids; vaccinations; nonpharmacological interventions and therapies; traditional Chinese medicines.
See the full eligibility criteria
Who can join
- The participant has a diagnosis of migraine as defined by ICHD-3 guidelines (section 1.1 Migraine without Aura, or 1.2.1 Migraine with typical Aura, or 1.3 Chronic Migraine) confirmed at the Screening Visit.
- The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
- The participant has a migraine onset at ≤50 years of age.
- The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- The participant fulfils the following criteria for EM or CM in prospectively collected information in the eDiary during the first 28 days of the Screening Period: o For participants with EM: migraine occurring on ≥4 days and headache occurring on <15 days o For participants with CM: migraine occurring on ≥8 days and headache occurring on ≥15 days and ≤26 days
- The participant has demonstrated compliance with the eDiary by entry of data for ≥24 of the 28 days following the Screening Visit.
- The participant has had treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications out of the following, of which at least one must be due to inadequate efficacy: o propranolol/metoprolol o topiramate o amitriptyline o flunarizine/lomerizine o candesartan o valproate/divalproex o botulinum toxin (if documented that botulinum toxin was taken for CM)
- The participant is aged ≥18 and ≤65 years at the Screening Visit
What rules you out
- The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
- The participant has a diagnosis of acute or active temporomandibular disorder.
- The participant has a history or diagnosis of chronic tension-type headache, cluster headache, headache attributed to trauma or injury to the head and/or neck, paroxysmal hemicrania, short lasting unilateral neuralgiform headache attacks, hemicrania continua, primary thunderclap headache, primary stabbing headache, nummular headache, new daily persistent headache, hypnic headache, trigeminal neuralgia, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness) or aura lasting >60 minutes.
- The following concomitant medications/substances are disallowed or allowed with restrictions (the list is not comprehensive): Disallowed: any investigational products within 30 days or 5 half-lives (whichever is longer) before the Screening Visit; preventive migraine treatments; anti-CGRP treatment; CNS- or migraine-related devices (neuromodulation, neurostimulation) or injectable therapies (such as trigger-point injections, extracranial nerve blocks, or facet joint injections); botulinum toxin; or monoamine oxidase inhibitors, ketamine, methysergide, methylergonovine, or nimesulide; immunosuppressants (for example, systemic steroids). Allowed with restriction: acute treatment of migraine (prescription or OTC medication), amphetamines, anti-impotence agents; barbiturates (including Fiorinal, Fioricet, or any other combination containing butalbital); opiates (including single-ingredient or combination medications containing opiates, opioids, tramadol, or tapentadol); cannabinoids; benzodiazepines; inhalation steroids; vaccinations; nonpharmacological interventions and therapies; traditional Chinese medicines.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.