A Phase 3 interventional study of Atogepant and Placebo for Atogepant in Chronic Migraine, sponsored by AbbVie. Recruiting at 66 sites in 11 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Among 21 studies testing atogepant in Migraine Disorders — 6 open to participants now, 7 under way, 4 of them phase 3. atogepant · Migraine Disorders.
Among the 21 studies testing atogepant in Migraine Disorders, this one is the 13th largest by planned enrollment, is one of 3 that started in 2025, is one of 15 in phase 3, and was the 18th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 420 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →6 of the 21 studies testing atogepant in Migraine Disorders are open now, in 12 countries. Each count lists the studies.
atogepant: first FDA approval 2021 (QULIPTA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 216 Migraine Disorders studies recruiting now, 65 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 36 take healthy volunteers.
This study: 12 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2025.
Median enrollment 468 across the 21 interventional studies. Of the 14 that completed or were terminated, 11 (79%) have results posted.
18 of 21 have an industry lead sponsor. The 5 most frequent:
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
26 studies in Migraine Disorders by AbbVie: 9 open now, 13 under way, 7 of them phase 3. Of 13 finished, 7 (54%) have results posted.
Among the 26 studies in Migraine Disorders by AbbVie, this one is the 13th largest by planned enrollment of the 18 interventional ones, is one of 3 that started in 2025, is one of 15 in phase 3, reaches primary completion later than 10 of the 12 other live ones, and was the 24th registered.
AbbVie’s Migraine Disorders studies by the year they started, since 2020.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing atogepant in Migraine Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AbbVie’s 26 in Migraine Disorders:
Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.
Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
During the last 28 days of the screening/baseline period, and as per eDiary:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive atogepant once daily for 12 weeks.
Drug: Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks.
Drug: Placebo for Atogepant
Oral tablet
Also known as: Qulipta, Aquipta
Oral tablet
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 16 weeks
Change From Baseline in Mean Monthly Migraine Days
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time frame: Baseline (Week 0) through Week 12
Change From Baseline in Mean Monthly Headache Days
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Time frame: Baseline (Week 0) through Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Time frame: Baseline (Week 0) through Week 12
Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Time frame: Baseline (Week 0) through Week 12
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score
The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.
Time frame: Baseline (Week 0) through Week 12
Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.
Time frame: Baseline (Week 0) through Week 12
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Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Started Feb 2025 (actual). Primary completion is estimated for Mar 2031, 73 months after the start.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 73 months is above that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Atogepant