fremanezumab for Chronic migraine

Inclusion criteria

• {"criterion_text":"- Informed and signed written consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n- Individuals of any sex, 18-70 years at the time of signing the informed consent.\n- Fulfilling the diagnosis chronic migraine criteria 1.3. according to the International Classification of Headache Disorders version 3 at the time of inclusion.\n- Indications for treatment with CGRP mAbs according to SmPCs\n- Indications for treatment with BTA according to SmPC.\n- No previous use of CGRP inhibitors or BTA.\n- Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 4 of the protocol."}

Exclusion criteria

• {"criterion_text":"- Contraindications, allergy or hypersensitivity reactions to BTA including infection at the injection site.\n- Contraindications, allergy or hypersensitivity reactions to CGRP mAbs including serious cardiovascular illness such as myocardial infarction, stroke, unstable angina pectoris, revascularization procedures last 12 months.\n- Concomitant medication overuse headache where drug withdrawal has not been done.\n- Subject is unable to differentiate migraine from other concomitant headaches\n- Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study inclusion (Visit 2).\n- Long-standing continuous headache with no headache free days or periods for a period oftime >1 years\n- Pregnancy, planning to get pregnant, inability to use contraceptives and lactating.\n- High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator\n- Alcohol or illicit drug dependence.\n- Investigators may exclude patients who, for various reasons (for example, severe psychiatric disorders), are considered unlikely to be able to complete the tasks required for participation in the study.\n- Inability to understand study procedures and to comply with them for the entire length of the study, assessed at the discretion of the investigator."}

Primary endpoints

• {"endpoint_text":"- Reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with the study medication","definition_or_measurement_approach":"Measured as change in Monthly Migraine Days (MMDs) over 12 weeks of treatment with the study medication."}

Secondary endpoints

• {"endpoint_text":"- Reduction of Monthly Headache Days (MHDs) over 12 weeks of treatment with the study medication\n- Monthly number of days with rescue medication over 12 weeks of treatment with the study medication.\n- Number of treatment responders (≥ 50%, ≥75% and 100 % reduction in MHD and MMDs over 12 weeks of treatment) at 12 weeks post-randomisation.\n- Number of weekly migraine days from baseline to 12 months post-randomization.\n- Total number of hours at moderate or severe pain over 12 weeks of treatment.\n- Number of treatment responders (≥ 30% reduction in mean MHDs over 12 weeks of treatment) at 12 weeks post-randomization.\n- Number of crystal-clear headache-free days after 12 weeks of treatment with the study medication.\n- Percentage of patients fulfilling the ICHD-3 diagnostic criteria for MOH over 12 weeks of treatment.\n- Number of patients completing the trial and number of dropouts.\n- Change in MIDAS over 12 weeks of treatment with the study medication.\n- Change in HADS-A and HADS-D score over 12 weeks of treatment with the study medication.\n- Change in Bergen Insomnia Scale over 12 weeks of treatment with the study medication\n- Change in Fatigue Score over 12 weeks of treatment with the study medication\n- Change in Mig-SCOG score over 12 weeks of treatment with the study medication\n- PGIC sum\n- Number of days on sick leave from baseline to 12 weeks post-randomization.\n- •\tNumber of treatment related adverse events (AEs) and treatment related serious adverse events (SAEs) over 12 weeks of treatment.\n- Costs and Quality of life measured by EQ-5D-5L before treatment initiation, and 12 weeks after treatment initiation\n- Absenteeism from work (salary, sick leave, social security). Presenteeism (lost workplace productivity), Productivity Cost\n- Treatment duration and dose intensity for trial treatments, adverse events (eCRF). Type and frequency of physician visits, emergency departments, general practitioner visits, hospitalizations. Other related resource use, including pharmaceuticals, transport, and time.","definition_or_measurement_approach":"Endpoints measured as described: mainly changes over 12 weeks (and where specified up to 12 months post-randomization) using counts of days (MHD, MMD), responder percentages, validated questionnaires (MIDAS, HADS, Bergen Insomnia Scale, Fatigue Score, Mig-SCOG), PGIC, AE/SAE reporting, and health-economic/resource use measures including EQ-5D-5L."}

Norway

Earliest CTIS Part Ii Submission Date

11-04-2025

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

186

Number Of Sites

12

Number Of Participants

450

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway