Clinical trial NCT06701526: A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications
Official title: Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Keywords: Eptinezumab
CGRP-targeting therapies
anti-CGRP monoclonal antibodies (mAbs)
Gepants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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 exclusion criteria apply.

Primary outcomes:
measure: Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale
timeFrame: Week 24
Secondary outcomes:
measure: Change from Baseline in Monthly Migraine Days (MMDs)
timeFrame: Weeks 1-12 and 13-24
measure: Change from Baseline in the Percentage of MMDs with Severe Pain Intensity
timeFrame: Weeks 1-12 and 13-24
measure: Change from Baseline in Monthly Headache Days (MHDs)
timeFrame: Weeks 1-12 and 13-24
measure: Change from Baseline in MMDs with Use of Acute Medication
timeFrame: Weeks 1-12 and 13-24
measure: Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale
timeFrame: Week 12
measure: PGIC Score
timeFrame: Weeks 12 and 24
measure: Change from Baseline in Migraine Disability Assessment (MIDAS) Scores
timeFrame: Weeks 12 and 24
measure: Goal Attainment Scaling (GAS) Score
timeFrame: Weeks 12 and 24
measure: Number of Participants with GAS Score ≥50
timeFrame: Weeks 12 and 24
measure: Change from Baseline in Number of Good Days per Month
timeFrame: Weeks 12 and 24
measure: Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score
timeFrame: Weeks 12 and 24
measure: Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog
timeFrame: Weeks 12 and 24
measure: Brain Fog Score
timeFrame: Weeks 12 and 24
measure: Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Change (CGIC) Scale
timeFrame: Weeks 12 and 24
measure: CGIC Score
timeFrame: Weeks 12 and 24
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 26
Other outcomes:
Locations:
city: Canton
country: United States
facility: Neuroscience Research Center, LLC
state: Ohio
Study officials:
References: