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A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lu AG09222
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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 at ≤50 years of age.
  • The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.

Key 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.

Sites / Locations

  • Excell Research - ClinEdge - PPDS
  • UNISON Clinical Trials (Shahram Jacobs md inc.)
  • Allied Biomedical Research Institute
  • Fakultni nemocnice u sv. Anny v Brne
  • CCR Ostrava s.r.o.
  • Mestska nemocnice Ostrava, p.o.
  • CCR Czech
  • CCR Prague s.r.o.
  • NEUROHK, s.r.o.
  • CLINTRIAL s.r.o.
  • FORBELI s.r.o.
  • INEP Medical s.r.o.
  • Rigshospitalet Glostrup-Nordre Ringvej 57
  • Aarhus Universitetshospital
  • Ltd Israel-Georgia Medical Research Clinic Helsicore
  • Archangel St Michael Multiprofile Clinical Hospital Ltd
  • Aversi Clinic LTD
  • LTD MediClubGeorgia
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
  • Ltd Multiprofile Clinic "Consilium Medulla"
  • Pratia MCM
  • Instytut Zdrowia Dr Boczarska-Jedynak
  • ETG Singua - PPDS
  • Centrum Medyczne Silmedic Sp z o o
  • Solumed SC
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
  • KONZILIUM s.r.o

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lu AG09222 High Dose

Lu AG09222 Low Dose

Placebo

Arm Description

Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.

Participants will receive a single low dose of Lu AG09222 by IV infusion.

Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4)

Secondary Outcome Measures

Percentage of Participants With ≥50% Reduction From Baseline in MMDs
Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4)

Full Information

First Posted
November 15, 2021
Last Updated
April 5, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05133323
Brief Title
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Official Title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. 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.
Detailed Description
Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AG09222 High Dose
Arm Type
Experimental
Arm Description
Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
Arm Title
Lu AG09222 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive a single low dose of Lu AG09222 by IV infusion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
Intervention Type
Drug
Intervention Name(s)
Lu AG09222
Intervention Description
Lu AG09222 will be administered per schedule specified in the arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4)
Time Frame
Baseline, Month 1 (Weeks 1-4)
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥50% Reduction From Baseline in MMDs
Time Frame
Baseline up to Month 1 (Weeks 1-4)
Title
Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4)
Time Frame
Baseline, Month 1 (Weeks 1-4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 at ≤50 years of age. The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications. Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
Excell Research - ClinEdge - PPDS
City
Oceanside
State/Province
California
ZIP/Postal Code
92056-4515
Country
United States
Facility Name
UNISON Clinical Trials (Shahram Jacobs md inc.)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-4630
Country
United States
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
CCR Ostrava s.r.o.
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Mestska nemocnice Ostrava, p.o.
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
CCR Czech
City
Pardubice
State/Province
Pardubicky Kraj
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CCR Prague s.r.o.
City
Praha
State/Province
Praha, Hlavní Mesto
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
NEUROHK, s.r.o.
City
Chocen
ZIP/Postal Code
565 01
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Prague
Country
Czechia
Facility Name
FORBELI s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
INEP Medical s.r.o.
City
Praha 8
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Rigshospitalet Glostrup-Nordre Ringvej 57
City
Glostrup
State/Province
Capital
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus N
State/Province
Central Jutland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Ltd Israel-Georgia Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Archangel St Michael Multiprofile Clinical Hospital Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Aversi Clinic LTD
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD MediClubGeorgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
Ltd Multiprofile Clinic "Consilium Medulla"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Pratia MCM
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak
City
Oswiecim
State/Province
Malopolskie
ZIP/Postal Code
32-600
Country
Poland
Facility Name
ETG Singua - PPDS
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Centrum Medyczne Silmedic Sp z o o
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Solumed SC
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-101
Country
Poland
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Facility Name
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
KONZILIUM s.r.o
City
Dubnica nad Vahom
ZIP/Postal Code
018 41
Country
Slovakia

12. IPD Sharing Statement

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A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

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