Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache.

INTERVENTION: Product Name: Eptinezumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: EPTINEZUMAB Current Sponsor code: Lu AG09221 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: 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 Primary end point(s): Change from baseline in the number of monthly migraine days (MMDs) Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Weeks 1‐12 SECONDARY OUTCOME: 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 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