Migraine and medication overuse headache MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10072720 Term: Medication overuse headache System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: VYEPTI
Product Name: VYEPTI
Product Code: ALD403
Pharmaceutical Form:
INN or Proposed INN: Eptinezumab
Current Sponsor code: Lu AG09221
Other descriptive name: ALD403
Concentration unit:
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. - The patient has a history of migraine onset of at least 12 months prior to the Screening Visit. - The patient has =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 guidelinesconfirmed at the Screening Visit. - The patient has =15 headache daysper monthfor 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 monthsprior to the Screening Visit. - The patient has =15 to =26 headache days, of which =8 days were assessed as migraine days during the screening period, based on prospectively collected information in the eDiary. - The patient overuses drugs that can be taken for acute treatment of headacheduring 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 Visitdue to lack of efficacy (no clinically meaningful improvement at the locally recommended dose for at least 3 months). - 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 migrainediagnosisat =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: - The patient has experienced failure on a previous preventive treatment targeting the CGRP pathwayincluding gepants for acute or preventive use. - The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). - 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 6months 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of eptinezumab as addition to BI for the prevention of migraine and treatment of MOH;Secondary Objective: - To evaluate the efficacy of eptinezumab as add-on to BI on health-related quality of life and work productivity - To evaluate the efficacy of eptinezumab during the 12-week open-label extension period;Primary end point(s): - Change from baseline in the number of MMDs ;Timepoint(s) of evaluation of this end point: (Weeks 1-4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in MMDs - Change from baseline in the number of MHDs - Change from baseline in MHDs - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH - Change from baseline in average Daily Pain assessment score - Change from baseline in monthly days with acute medication use - Change from baseline in monthly days with acute medication use ;Timepoint(s) of evaluation of this end point: - Change from baseline in MMDs (Weeks 1-12) - Change from baseline in the number of MHDs (Weeks 1-4) - Change from baseline in MHDs (Weeks 1-12) - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 4) - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 12) - Change from baseline in average Daily Pain assessment score (Weeks 1-2) - Change from baseline in monthly days with acute medication use (Weeks 1-4) - Change from baseline in monthly days with acute medication use (Weeks 1-12) | — |
Countries
Australia, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed