Migraine in patients with unsuccessful prior preventive treatments MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit • The patient has a migraine onset of =50 years of age. • The patient has =4 migraine days per month for each month within the past 3 months prior to the Screening Visit. • 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 fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period: • For patients with CM: Migraine occurring on =8 days and headache occurring on >14 days • For patients with EM: Migraine occurring on =4 days and headache occurring on =14 days • The patient has documented evidence of treatment failure (must be supported by medical record or by physician’s confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications. • The patient has a history of either previous or active use of triptans for migraine. Other inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 715 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway. • The patient has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications. • The patient has confounding and clinically significant pain syndromes, (e.g., fibromyalgia, chronic low back pain, complex regional pain syndrome). • The patient has a diagnosis of acute or active temporomandibular disorder. • 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), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). • The patient has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Patients with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded. • The patient has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of eptinezumab in the prevention of migraine in patients with unsuccessful prior preventive treatments To evaluate the efficacy of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments;Secondary Objective: N/A;Primary end point(s): 1. Change from baseline in the number of monthly migraine days;Timepoint(s) of evaluation of this end point: 1. [Time Frame: From Baseline to Weeks 1-12] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Response: patients with 50% reduction from baseline in monthly migraine days 3. Change from baseline in the number of monthly migraine days 4. Response: patients with 75% reduction from baseline in monthly migraine days 5. Response: patients with 100% reduction from baseline in monthly migraine days 6. Response: patients with 50% reduction from baseline in monthly headache days 7. Response: patients with 75% reduction from baseline in monthly headache days 8. Response: patients with 100% reduction from baseline in monthly headache days 9. Change from baseline in the number of monthly headache days 10. Migraine/headaches with severe pain intensity 11. Change from baseline in the number of monthly migraine days with use of acute medication 12. Patient Global Impression of Change (PGIC) score The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse) 13. Change from baseline in the number of monthly migraine days in patients with Medication Overuse Headache (MOH) 14. Number of Patients with a migraine on the day after first dosing 15. Change in Most Bothersome Symptom (MBS) score Patients will identify a migraine-related symptom that is most bothersome for them. Patients will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity with sound 16. Change from baseline in the Headache Impact Test (HIT-6) score 17. Change from baseline in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function) 18. Change from baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score 19. Change from baseline in Health Care Resources Utilisation (HCRU) score 20. Change from baseline in work productivity | — |
Countries
Belgium, Bulgaria, Czechia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Hungary, Italy, Poland, Russian Federation, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed