Chronic migraine MedDRA version: 21.1 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852
Conditions
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 screening visit with a history of migraine onset at least 12 months prior to the Screening Visit. • The patient has had a diagnosis of migraine at =65 years) yes F.1.3.1 Number of subjects for this age range 113
Exclusion criteria
Exclusion criteria: • The patient has received any medication targeting the calcitonin generelated peptide (CGRP) pathway as preventive treatment of migraine. • The patient has confounding and clinically significant pain syndromes, (for example, 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, 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 a lifetime history of psychosis, bipolar mania, or dementia. • Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded. • 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). Other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study evaluates the efficacy of eptinezumab to prevent migraine in patients with chronic migraine;Secondary Objective: Not applicable;Primary end point(s): 1. Change from baseline in the number of monthly migraine days (MMDs);Timepoint(s) of evaluation of this end point: 1. Weeks 1-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Response: =50% reduction from baseline in MMDs 3. Response: =75% reduction from baseline in MMDs 4. Response: =75% reduction from baseline in MMDs 5. Migraine rate on the day after dosing 6. Response: =50% reduction from baseline in monthly headache days (MHDs) 7. Change from baseline in the number of MHDs 8. Response: =75% reduction from baseline in MHDs 9. Change from baseline in rate of migraines with severe pain intensity 10. Change from baseline in rate of headaches with severe pain intensity 11. Change from baseline in the number of MMDs with use of acute medication 12. Patient Global Impression of Change (PGIC) score at week 12 13. Change from baseline to Week 12 in Most Bothersome Symptom (MBS) score 14. Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score 15. Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) 16. Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score 17. Health Care Resources Utilization (HCRU) Migraine-specific healthcare resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays. 18. Change from baseline to Week 12 in the Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment);Timepoint(s) of evaluation of this end point: 2. Weeks 1-12 3. Weeks 1-4 4. Weeks 1-12 5. Day 1 6. Weeks 1-12 7. Weeks 1-12 8. Weeks 1-4 9. Weeks 1-12 10. Weeks 1-12 11. Weeks 1-12 12. Week 12 13. Baseline to Week 12 14. Baseline to Week 12 15. Baseline to Week 12 16. Baseline to Week 12 17. Baseline to Week 12 18. Baseline to Week 12 | — |
Countries
China, Georgia, Japan, Korea, Republic of, Spain, Taiwan
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed