Preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache
Conditions
Sponsors
H. Lundbeck A/S (Lundbeck)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has a diagnosis of migraine as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit. 2. The patient has =8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit. 3. The patient has a diagnosis of MOH as defined by IHS ICHD-3 guidelines. 4. The patient has headache on =15 days/month for each month within the past 3 months prior to the Screening Visit. 5. The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for >3 months. 6. 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. 7. The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary. 8. The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period. 9. The patient has had an onset of migraine at =65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: 1. The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway. 2. The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome). 3. The patient has a diagnosis of acute or active temporomandibular disorder. 4. 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). 5. Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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. 6. 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 and headache in patients with the combined diagnosis of migraine and medication overuse headache;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in the number of monthly migraine days (MMDs);Timepoint(s) of evaluation of this end point: Weeks 1-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in MMDs with use of acute medication 2. Response: =50% reduction from baseline in MMDs 3. Migraine rate on the day after dosing (Day 1) 4. Response: =75% reduction from baseline in MMDs 5. Change from baseline in the number of monthly headache days (MHDs) 6. Response: =75% reduction from baseline in MMDs 7. Response: =75% reduction from baseline in MHDs 8. Response: =75% reduction from baseline in MHDs 9. Change from baseline in the number of MHDs with use of acute medication 10. Change from baseline in rate of migraines with severe pain intensity 11. Change from baseline in rate of headaches with severe pain intensity 12. Patient Global Impression of Change (PGIC) score 13. Most Bothersome Symptom (MBS) (score measured relative to Screening);Timepoint(s) of evaluation of this end point: 1. Weeks 1-12 2. Weeks 1-12 3. Day 1 4. Weeks 1-4 5. Weeks 1-12 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. Weeks 12 13. Weeks 12 | — |
Countries
China, Georgia, Korea, Republic of, Spain, Taiwan
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S.
Outcome results
None listed