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Long-term Extension Study to Assess Adverse Events and Tolerability of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
EU CTIS ID: 2022-501099-24-00
What this study is testing
To evaluate the long-term safety and tolerability of atogepant treatment for the prevention of migraine in pediatric participants 6 to 17 years of age.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be between 6 and 17 years of age (inclusive), with a history of episodic or chronic migraine.
- Participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201 or the lead-in Study M23-712.
- 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.
You likely can't join if
- History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- Have a current diagnosis of new daily persistent 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Israel
- United States
- Puerto Rico
- Canada
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Israel; United States; Puerto Rico; Canada; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.