A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine (PROSPECT-2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

H. Lundbeck A/S

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

8 Nov 2022 → ongoing

Decision date (initial)

2024-09-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

H. Lundbeck A/S

External identifiers

EU CT number

2024-510656-13-00

EudraCT number

2020-001009-22

ClinicalTrials.gov

NCT04965675

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Prophylaxis

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Conditions and MedDRA coding

Migraine

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-002243-PIP01-17

Plan to share IPD

Yes

IPD plan description

Please visit www.lundbeck.com for information about our clinical data sharing policy and processes.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
2. During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
3. During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Exclusion criteria 4

1. The participant has previously been randomised in this study and exposed to eptinezumab.
2. The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
3. The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
4. The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), 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), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. "Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "

Secondary endpoints 13

1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
2. Percentage of Participants With Migraine on the Day After Dosing (Day 1)
3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
11. Free Eptinezumab Plasma Concentration
12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

Investigational products

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

Test 1

Placebo 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 7

Locations

4 EU/EEA countries · 22 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

Documents 65 files

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

Application history

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