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
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. - The participant has 8 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The participant has 15 headache days per month for each month within the past 3 months prior to the Screening Visit. - The participant has had an onset of migraine diagnosis at =50 years of age. 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 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: - The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). - The participant has a diagnosis of acute or active temporomandibular disorders. - The participant 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 participant 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 6 months prior to the Screening Visit. - The participant 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: Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and 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 Monthly Migraine Days (MMDs);Timepoint(s) of evaluation of this end point: Baseline to Weeks 1-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Change from baseline in MMDs 2 Change from baseline in the number of Monthly Headache Days (MHDs) 3 Change From Baseline in Average Daily Pain Assessment Score 4 Change From Baseline in Monthly Days with Acute Medication Use 5 Percentage of Participants Not Fulfilling the lnternational Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) 6 Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH 7 Change From Baseline in MMDs with Acute Medication Use 8 Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics) 9 Percentage of Participants with Migraine on the Day After Dosing 10 Response: =50% Reduction From Baseline in MMDs 11 Response: =75% Reduction From Baseline in MMDs 12 Response: =50% Reduction From Baseline in MHDs 13 Response: =75% Reduction From Baseline in MHDs 14 Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity 15 Patient Global Impression of Change (PGIC) Score 16 Change in Most Bothersome Symptom (MBS) Score 17 Change From Baseline in the Headache Impact Test (HIT-6) Total score 18 Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score 19 Change From Baseline in the Migraine-Specific Quality of Life (MSQv2.1) Sub-Scores 20 Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score 21 Change From Baseline in Health Care Resources Utilisation (HCRU) Score 22 Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores 23 Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores 24 Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score;Timepoint(s) of evaluation of this end point: -1, 7, 8, 16: Weeks 1-12 and Weeks 13-24 -2, 4, 5, 6: Weeks 1-4, Weeks 1-12 and We | — |
Countries
Australia, Denmark, Germany, Italy, Netherlands, Norway, Spain, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed