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Atogepant for Pediatric Migraine
Study Summary
This trial will evaluate the long-term safety and tolerability of atogepant in pediatric participants between ages 6-17 with episodic migraine. 250 participants worldwide will receive atogepant for 52 weeks & will attend regular visits to check for side effects.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 744 Patients • NCT03700320Trial Design
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- I have been diagnosed with a specific type of migraine.I have had migraines for at least 6 months.I am between 6 and 17 years old and have a history of migraine attacks.I have been diagnosed with chronic migraine or a specific headache disorder.I have a serious health condition affecting my blood, hormones, lungs, kidneys, liver, stomach, heart, or nervous system.My weight is between 44 lbs and 298 lbs.
- Group 1: Atogepant Dose A (12-17 yrs)
- Group 2: Atogepant Dose B (6-11 yrs)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is it permissible for individuals under the age of eighteen to join this clinical research?
"This clinical trial's enrollment requirements stipulate that participants are aged between 6 and 17 years old. There are 31 studies available for minors, whereas those over 65 can choose from 106 different options."
What health hazards are associated with Atogepant Dose A for adolescents in the 12-17 age range?
"There is prior clinical evidence that attests to Atogepant Dose A (12-17 yrs)'s safety, thus it was evaluated as a 3 on our scale."
Are there any available slots for participants in this clinical trial?
"Clinicaltrials.gov indicates that this investigation is not currently seeking patients, despite having been posted on March 9th 2023 and last updated on January 24th of the same year. However, 155 other research initiatives are actively enrolling participants at present."
In what geographic areas is this investigation being conducted?
"The recruitment phase of this trial is currently operating in 43 distinct medical centres. Areas close to Huntsville, Little Rock and Anaheim are among those enrolled; other sites exist throughout the United States. To reduce travel burden, it's best to choose a clinic located near you if you're interested in taking part."
Who meets the criteria to join this medical experiment?
"This clinical trial is aiming to recruit 250 minors aged between 6 and 17 who are suffering from migraine with aura. To be enrolled, participants must meet the following requirements: being between 6-17 years old (inclusive), having a history of episodic migraine, completing Study M21-201 or its PK substudy, weighing at least 20 kg but less than 135kg, presenting a past consistent with ICHD-3 diagnosis for more than half a year and deemed an appropriate candidate by their investigator to receive daily preventive treatment using Atogepant (except in de novo cases)."
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