A Study to Assess the Adverse Events and Change in Disease Activity of Atogepant Oral Tablets in Pediatric Participants with Chronic Migraine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

23 Jun 2025 → ongoing

Decision date (initial)

2025-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2024-513836-28-00

ClinicalTrials.gov

NCT06810505

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

The primary objective is to evaluate the safety and efficacy of atogepant when administered daily for the preventive treatment of chronic migraine in pediatric subjects 12 to 17 years of age.

Secondary objectives 1

1. The secondary efficacy objective of the study is to evaluate the efficacy of preventive treatment with atogepant when compared to placebo with respect to the secondary endpoints in pediatric subjects 12 to 17 years of age with chronic migraine.

Conditions and MedDRA coding

Chronic Migraine

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002530-PIP01-18

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds).
2. Subject has a history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
3. Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the treatment of migraine.

Exclusion criteria 2

1. Migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
2. Current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period

Secondary endpoints 6

1. Change from Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
2. Change from Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period.
3. Percentage of Participants who Achieve at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days.
4. Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score at Week 12.
5. Change from Baseline on the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score at Week 12.
6. Change from baseline in mean monthly headache days of at least moderate severity across the 12-week treatment period.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 9

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 55 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