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OmaMig Pilot: An open-label, phase IIa, single arm pilot study evaluating the potential clinical benefit and safety of omalizumab in adults with episodic migraine.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522448-41-00
Enrollment
25
Registered
2026-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodic migraine

Brief summary

Change in number of migraine days from screening period (week -4 –baseline) to week 8–12.

Detailed description

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

Interventions

DRUGXolair 300 mg solution for injection in pre-filled syringe

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in number of migraine days from screening period (week -4 –baseline) to week 8–12.

Secondary

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

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 1, 2026