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CGRP Antagonist
Oral Atogepant Tablets for Migraine (ATO EM PEDS Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 (ICHD) -3 (2018) for at least 6 months.
Must not have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to 3 months
Awards & highlights
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored through medical assessments and blood tests. Side effects could include typical drug reactions such as nausea, fatigue, digestive issues or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is between 44 lbs and 298 lbs.
Select...
I have been diagnosed with migraines, with or without aura, for at least 6 months.
Select...
I experience 4 to 14 migraine days and less than 15 headache days in a month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had specific severe migraines, as defined by a 2018 standard.
Select...
I have been diagnosed with chronic migraines.
Select...
I have been diagnosed with a specific type of severe headache or facial pain.
Select...
I've been hospitalized for migraine 3+ times in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Mean Monthly Migraine Days
Secondary study objectives
Change from Baseline in Mean Monthly Acute Medication Use Days
Change from Baseline in Mean Monthly Headache Days
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
CGRP receptor antagonists, such as Atogepant, work by blocking the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating trigeminovascular pain transmission and neurogenic inflammation associated with migraines. This mechanism helps reduce the frequency and severity of migraine attacks.
Other common treatments include NSAIDs and acetaminophen, which alleviate pain by reducing inflammation and blocking pain signals, and triptans, which activate serotonin receptors to constrict blood vessels and reduce inflammation. Understanding these mechanisms is vital for migraine patients as it helps tailor treatment plans to effectively manage symptoms and improve quality of life.
Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.
Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,129 Total Patients Enrolled
14 Trials studying Migraine
12,263 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
163,914 Total Patients Enrolled
14 Trials studying Migraine
12,263 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had specific severe migraines, as defined by a 2018 standard.I am between 6 to 11 years old and need preventive treatment for my migraines.I have been diagnosed with a specific type of severe headache or facial pain.My weight is between 44 lbs and 298 lbs.I experience 4 to 14 migraine days and less than 15 headache days in a month.I have been diagnosed with chronic migraines.I have been diagnosed with migraines, with or without aura, for at least 6 months.I've been hospitalized for migraine 3+ times in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
- Group 2: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
- Group 3: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
- Group 4: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
- Group 5: Double-Blind Treatment Period: Placebo (12-17 yrs)
- Group 6: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
- Group 7: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
- Group 8: Double-Blind Treatment Period: Placebo (6-11 yrs)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.