Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing a medication called atogepant to treat migraines in children and teenagers aged 6 to 17. The study aims to see if atogepant is safe and effective for this age group. Atogepant helps by blocking a protein that triggers migraines, potentially reducing their occurrence and intensity. Atogepant is a newly approved oral medication for the prevention of episodic migraine in adults.
Is the drug Atogepant a promising treatment for migraine?Yes, Atogepant is a promising drug for preventing migraines. It has been approved in the USA for adults with episodic migraines and is being tested in other countries. It is taken as a pill and works by blocking a specific protein related to migraines, showing good results in trials.12457
What safety data is available for atogepant in migraine treatment?The safety of atogepant has been evaluated in multiple studies. A phase 3 trial assessed its long-term safety, tolerability, and efficacy for migraine prevention. Additionally, a phase 2b/3 trial examined various doses for safety and tolerability. Atogepant, marketed as Qulipta, was approved in the USA in September 2021 for the preventive treatment of episodic migraine in adults, indicating a favorable safety profile.12467
What data supports the idea that Oral Atogepant Tablets for Migraine is an effective drug?The available research shows that Oral Atogepant Tablets are effective for preventing migraines. In a study, people who took the drug daily experienced fewer migraine days compared to those who took a placebo, which is a pill with no active medicine. This suggests that Atogepant helps reduce the frequency of migraines, making it a useful option for people who suffer from this condition.12347
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Eligibility Criteria
This trial is for kids aged 6-17 with episodic migraines, weighing between 44 and 298 lbs. They must have had 4 to 14 migraine days in the past month but less than 15 headache days overall. It's not for those with certain other headaches or who've needed hospital treatment for migraines three times in six months.Inclusion Criteria
My weight is between 44 lbs and 298 lbs.
I have been diagnosed with migraines, with or without aura, for at least 6 months.
I experience 4 to 14 migraine days and less than 15 headache days in a month.
Exclusion Criteria
I have had specific severe migraines, as defined by a 2018 standard.
I have been diagnosed with chronic migraines.
I have been diagnosed with a specific type of severe headache or facial pain.
I've been hospitalized for migraine 3+ times in the last 6 months.
Treatment Details
The study tests low and high doses of atogepant, a migraine medication approved for adults, now being studied in children. Participants are randomly assigned to receive either a placebo or atogepant daily for twelve weeks, with some continuing up to a year.
8Treatment groups
Experimental Treatment
Group I: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Group II: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Group III: Double-Blind Treatment Period: Placebo (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Group IV: Double-Blind Treatment Period: Placebo (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Group V: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Group VI: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Group VII: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)Experimental Treatment1 Intervention
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Group VIII: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)Experimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Atogepant is already approved in United States for the following indications:
🇺🇸 Approved in United States as Qulipta for:
- Preventive treatment of migraine in adults
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 248546Stockbridge, GA
Northern Alberta Clinical Trials & Research Centre /ID# 249672Edmonton, Canada
Children's Hospital of Eastern Ontario /ID# 247268Ottawa, Canada
MCB Clinical Research Centers /ID# 247456Colorado Springs, CO
More Trial Locations
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Who is running the clinical trial?
AbbVieLead Sponsor
References
Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. [2020]Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine. We aimed to examine a range of oral doses for safety, tolerability, and efficacy for the preventive treatment of migraine.
Atogepant for the Preventive Treatment of Migraine. [2021]Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist that is being investigated for the preventive treatment of migraine.
Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. [2022]Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine.
Atogepant: First Approval. [2022]Atogepant (Qulipta™) is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed by AbbVie for the prophylaxis of migraine. In September 2021, atogepant was approved in the USA for the preventive treatment of episodic migraine in adults. The drug is also in phase 3 clinical development for the preventive treatment of migraine in various other countries. This article summarizes the milestones in the development of atogepant leading to this first approval for the preventive treatment of episodic migraine in adults.
Atogepant for Migraine Prevention: A Systematic Review of Efficacy and Safety. [2022]Atogepant is the latest calcitonin gene-related peptide (CGRP) antagonist approved exclusively for prophylaxis of episodic migraine and is administered orally in doses of 10-60 mg/day. This article aims to provide a systematic review of the efficacy and safety of atogepant in migraine prevention.
Atogepant for the prevention of episodic migraine in adults. [2023]Atogepant is a newly approved medication for the prevention of migraine. This review aims to discuss the efficacy, safety, cost, and place in therapy of atogepant.
Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. [2023]To assess long-term safety, tolerability, and efficacy of once-daily oral atogepant 60 mg in adults with migraine.