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; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 100000004852

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 19 April 2022

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines.<br>People who join this trial have at least 8 days a month with a migraine. They have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them.<br>When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.<br>;Secondary Objective: N/A;Primary end point(s): 1. Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4) ;Timepoint(s) of evaluation of this end point: Time Frame: Baseline, Month 1 (Weeks 1-4)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Percentage of Participants With =50% Reduction From Baseline in MMDs<br>2. Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4) ;Timepoint(s) of evaluation of this end point: Secondary Endpoints:<br>1. Time Frame: Baseline up to Month 1 (Weeks 1-4) <br>2. Time Frame: Baseline, Month 1 (Weeks 1-4)