Omalizumab for Episodic migraine

Inclusion criteria

• {"criterion_text":"- Adults with episodic migraine and 4–14 migraine days pr month with or without aura according to the International Classification of Headache Disorders (ICHD-3)"}

Exclusion criteria

• {"criterion_text":"- Use of other migraine preventives during the study.\n- Interval headache not distinguishable from migraine.\n- Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years.\n- Breastfeeding or pregnancy"}

Primary endpoints

• {"endpoint_text":"- Change in number of migraine days from screening period (week -4 –baseline) to week 8–12.","definition_or_measurement_approach":"Change in number of migraine days from screening period (week -4 –baseline) to week 8–12."}

Secondary endpoints

• {"endpoint_text":"- Incidence of adverse events (AEs) and serious adverse events (SAEs) at 16 weeks","definition_or_measurement_approach":"Incidence of adverse events (AEs) and serious adverse events (SAEs) at 16 weeks"}
• {"endpoint_text":"- Suspected unexpected serious adverse reaction (SUSAR).","definition_or_measurement_approach":"Suspected unexpected serious adverse reaction (SUSAR)."}
• {"endpoint_text":"- Withdrawals","definition_or_measurement_approach":"Withdrawals"}
• {"endpoint_text":"- Intensity and duration","definition_or_measurement_approach":"Intensity and duration"}
• {"endpoint_text":"- Type and dose of medication","definition_or_measurement_approach":"Type and dose of medication"}
• {"endpoint_text":"- Self-assessed efficacy of rescue treatment","definition_or_measurement_approach":"Self-assessed efficacy of rescue treatment"}
• {"endpoint_text":"- ≥50% reduction in attack frequency (week -4 –baseline) to week 8–12","definition_or_measurement_approach":"≥50% reduction in attack frequency between screening period (week -4 –baseline) and week 8–12"}
• {"endpoint_text":"- Numbers of patients within each category at 12 weeks","definition_or_measurement_approach":"Numbers of patients within each category at 12 weeks"}
• {"endpoint_text":"- Reported IgE value at baseline and 16 weeks","definition_or_measurement_approach":"Reported IgE value at baseline and at 16 weeks"}
• {"endpoint_text":"- Change in number of migraine days from screening period (week -4 –baseline) to week 12–16","definition_or_measurement_approach":"Change in number of migraine days from screening period (week -4 –baseline) to week 12–16"}

Norway

Earliest CTIS Part Ii Submission Date

25-02-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

34

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway