A Study With Lu AG09222 in Adults With Migraine who Have not Been Helped by Prior Preventive Treatment

Phase 1

• Conditions: Prevention of migraine in patients with unsuccessful prior preventive treatments; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-005924-12-CZ
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

- The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
- The participant has a history of migraine onset at least 12 months prior to the Screening Visit.
- The participant has a migraine onset of =50 years of age.
- The participant has =8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- The participant fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
- Migraine occurring on =8 days and headache occurring on =26 days.
- The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
- The participant has confounding and clinically significant pain syndromes.
- The participant has a diagnosis of acute or active temporomandibular disorder.
- The participant has a history or diagnosis of confounding headaches.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified