Migraine
Conditions
Keywords
Eptinezumab, CGRP-targeting therapies, anti-CGRP monoclonal antibodies (mAbs), Gepants
Brief summary
The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).
Interventions
DRUGEptinezumab
Solution for infusion
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The participant has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to the Screening Visit. * The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. * The participant has documented evidence of recent inadequate response to either one anti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant, indicated and used for migraine prevention. Key
Exclusion criteria
* The participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period. * The participant has previously had an inadequate response to more than one CGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraine prevention. * The participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of eptinezumab. Male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. Participants under surveillance for a low and stable level of M-component are allowed. * The participant has previously been treated with eptinezumab. Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Monthly Migraine Days (MMDs) | Weeks 1-12 and 13-24 |
| Change from Baseline in the Percentage of MMDs with Severe Pain Intensity | Weeks 1-12 and 13-24 |
| Change from Baseline in Monthly Headache Days (MHDs) | Weeks 1-12 and 13-24 |
| Change from Baseline in MMDs with Use of Acute Medication | Weeks 1-12 and 13-24 |
| Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale | Week 12 |
| PGIC Score | Weeks 12 and 24 |
| Change from Baseline in Migraine Disability Assessment (MIDAS) Scores | Weeks 12 and 24 |
| Goal Attainment Scaling (GAS) Score | Weeks 12 and 24 |
| Number of Participants with GAS Score ≥50 | Weeks 12 and 24 |
| Change from Baseline in Number of Good Days per Month | Weeks 12 and 24 |
| Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score | Weeks 12 and 24 |
| Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog | Weeks 12 and 24 |
| Brain Fog Score | Weeks 12 and 24 |
| Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Change (CGIC) Scale | Weeks 12 and 24 |
| CGIC Score | Weeks 12 and 24 |
| Number of Participants with Adverse Events (AEs) | Up to Week 26 |
Countries
United States
Contacts
STUDY_DIRECTOREmail contact via H. Lundbeck A/S
HQ_Medinfo@Lundbeck.com
Outcome results
None listed