OmaMig Pilot

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-03-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Prophylaxis

Evaluate the potential clinical benefit on monthly migraine days.

Secondary objectives 7

1. To gather evidence of the safety of using omalizumab in patients with migraine.
2. Intensity and duration of migraine attacks
3. Rescue medication
4. Responder rate
5. Patient satisfaction
6. To gather data on baseline and changes in IgE values in migraineurs and if IgE values can help inform clinical decision making.
7. Evaluate the potential clinical benefit on monthly migraine days

Conditions and MedDRA coding

Episodic migraine

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 4

1. Use of other migraine preventives during the study.
2. Interval headache not distinguishable from migraine.
3. Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years.
4. Breastfeeding or pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 10

1. Incidence of adverse events (AEs) and serious adverse events (SAEs) at 16 weeks
2. Suspected unexpected serious adverse reaction (SUSAR).
3. Withdrawals
4. Intensity and duration
5. Type and dose of medication
6. Self-assessed efficacy of rescue treatment
7. ≥50% reduction in attack frequency (week -4 –baseline) to week 8–12
8. Numbers of patients within each category at 12 weeks
9. Reported IgE value at baseline and 16 weeks
10. Change in number of migraine days from screening period (week -4 –baseline) to week 12–16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Elisabeth Gjefsen

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Elisabeth Gjefsen

Sponsor responsibilities

Article 77 compliance

Oslo University Hospital HF

Contact point sponsor

Oslo University Hospital HF

Article 77 implementation

Oslo University Hospital HF

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications