A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

Phase 1

Recruiting

• Conditions: Episodic Migraine; MedDRA version: 20.0Level: PTClassification code: 10052787Term: Migraine without aura Class: 100000004852; MedDRA version: 22.0Level: LLTClassification code: 10082019Term: Episodic migraine Class: 10029205; MedDRA version: 20.0Level: PTClassification code: 10027607Term: Migraine with aura Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-501100-94-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-03
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs)., History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months., Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary., To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria

History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018)., Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018)., Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018)., Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of two doses of atogepant (low and high) when administered daily for the treatment of episodic migraine in pediatric participants 6 to 17 years of age.;Secondary Objective: The secondary efficacy objective of the study is to demonstrate improvement in efficacy for treatment with atogepant when compared to placebo with respect to the secondary endpoints.;Primary end point(s): Change from baseline in mean monthly migraine days across the 12-week treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from baseline in mean monthly headache days across the 12-week treatment period.;Secondary end point(s):Change from baseline in mean monthly acute medication use days across the 12-week treatment period.;Secondary end point(s):Achievement of at least a 50% reduction in 3-month average of monthly migraine days.;Secondary end point(s):Change from baseline in the PedsQL total score at Week 12.;Secondary end point(s):Change from baseline in the PedMIDAS total score at Week 12.