ong-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine

Phase 1

Recruiting

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

• Registration Number: CTIS2022-501099-24-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine., The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants), Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs)., 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.

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 any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Study & Design

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