Episodic Migraine study: Atogepant
Official title 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
ClinicalTrials.gov ID: NCT05711394
What this study is testing
What is Atogepant?
An investigational oral tablet being studied as a potential treatment for episodic migraine in children and teens. It is designed to block the CGRP receptor, which is involved in migraine pathways.
Also referred to as Qulipta, AGN-241689.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a medicine called atogepant works well and is safe. It also checks for any side effects in young people with migraines.
- Who it's for
- You may be able to join if you are between 6 and 17 years old. You must have a history of getting migraines from time to time.
- What's involved
- You would take a pill by mouth once a day. You would get a real medicine or a pretend pill with no medicine. Neither you nor the team knows which one you get.
- Time commitment
- The main part lasts 12 weeks with regular visits to a clinic. You may stay for up to a year to keep taking the medicine.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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 (consistent with a diagnosis...
You likely can't join if
- History of migraine brainstem aura, 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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as...
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Saraland, Alabama, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Long Beach, California, United States
- San Jose, California, United States
- Walnut Creek, California, United States
- Miami, Florida, United States
- Brunswick, Georgia, United States
- Newburgh, Indiana, United States
- Ann Arbor, Michigan, United States
- Ridgeland, Mississippi, United States
- Morristown, New Jersey, United States
- Amherst, New York, United States
- Greensboro, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Friendswood, Texas, United States
+ 44 more site(s).
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, but 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, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Saraland, Alabama, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Long Beach, California, United States; San Jose, California, United States and 58 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.