Eptinezumab as Preventive Treatment of Migraine in Adults with Migraine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

H. Lundbeck A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

5 Jul 2021 → 17 Feb 2025

Decision date (initial)

2024-04-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

H. Lundbeck A/S

External identifiers

EU CT number

2023-510183-12-00

EudraCT number

2020-001657-42

ClinicalTrials.gov

NCT04921384

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Prophylaxis, Efficacy

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

Conditions and MedDRA coding

Chronic migraine

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • The participant has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit. • The participant has had a diagnosis of migraine at <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 ≥15 to ≤26 days. • The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit. • The participant is aged ≥18 (≥20 for Taiwan) and ≤75 years at the Screening Visit. Other inclusion criteria may apply

Exclusion criteria 1

1. • The participant has received any medication targeting the calcitonin generelated peptide (CGRP) pathway as preventive treatment of migraine. • The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome). • The participant has a diagnosis of acute or active temporomandibular disorder. • The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). • The participant has a lifetime history of psychosis, bipolar mania, or dementia. • Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded. • The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other exclusion criteria may apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in the number of monthly migraine days (MMDs) Timepoint(s) of evaluation of this end point: Weeks 1-12

Secondary endpoints 4

1. Response: ≥50% reduction from baseline in MMDs (Weeks 1-12)
2. Response: ≥75% reduction from baseline in MMDs (Weeks 1-4)
3. Response: ≥75% reduction from baseline in MMDs (Weeks 1-12)
4. Migraine rate on the day after dosing (Day 1)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

H. Lundbeck A/S

Sponsor organisation

H. Lundbeck A/S

Address

Ottiliavej 9

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

H. Lundbeck A/S

Contact name

Global Trial Lead

Public contact point

Organisation

H. Lundbeck A/S

Contact name

Global Trial Lead

Third parties 6

Locations

3 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications