A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

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

1 Sep 2022 → 2 Apr 2025

Decision date (initial)

2024-04-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-510729-24-00

EudraCT number

2021-003049-40

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of Eptinezumab as add-on to BI for the prevention of migrane and treatment of MOH

Conditions and MedDRA coding

Chronic Migrane, Migrane, Medication Overuse Headache

Study design 4 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002243-PIP01-17

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
2. The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
3. The patient has had an onset of migraine diagnosis at ≤50 years of age.
4. The patient has a history of migraine onset of at least 12 months prior to the Screening Visit.
5. The patient has 2:8 migraine days per month for each month within the past 3 months prior to the Screening Visit
6. The patient has a diagnosis of MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.D92
7. The patient has 2:15 headache days per month for each month within the past 3 months prior to the Screening Visit.
8. The patient has regular overuse of one or more drugs that can be taken for acute treatment of headache, for >3 months prior to the Screening Visit.
9. The patient has 2:15 headache days, of which 2:8 days were assessed as migraine days during the screening period, based on prospectively collected information in the eDiary.
10. The patient overuses drugs that can be taken for acute treatment of headache during the screening period, based on prospectively collected information in the eDiary.
11. The patient has a history of treatment failure with at least 1 preventive treatment within the last 5 years prior to the Screening Visit.
12. The patient is aged 2:18 and S.75 years at the Screening Visit.C97

Exclusion criteria 6

1. The patient has a history of treatment failure with a previous preventive treatment targeting the CGRP pathway including gepants for acute or preventive use within the last 5 years prior to the Screening Visit.
2. The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).C103
3. The patient has a diagnosis of acute or active temporomandibular disorders.
4. The patient 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
5. The patient has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
6. The patient 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in the number ofMHDs (Weeks 1-4)

Secondary endpoints 8

1. Change from baseline in MMDs (Weeks 1-12)
2. Change from baseline in MHDs (Weeks 1-12)
3. Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 4)
4. Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 12)
5. Change from baseline in average Daily Pain assessment score (Weeks 1-2)
6. Change from baseline in monthly days with acute medication use (Weeks 1-4)
7. Change from baseline in monthly days with acute medication use (Weeks 1-12
8. Change from baseline in the number ofMHDs (Weeks 1-4)

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

[email protected]

Public contact point

Organisation

H. Lundbeck A/S

Contact name

[email protected]

Third parties 3

Locations

8 EU/EEA countries · 55 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 48 files

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

Application history

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