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NCT Number: NCT06810505

A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

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.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
  • During the last 28 days of the screening/baseline period, and as per eDiary:
  • Participant must have completed the eDiary for a minimum of 20 out of 28 days.
  • Participant has >= 15 headache days.
  • Participant has >= 8 migraine days.

Exclusion criteria

  • Clinically significant hypertension per investigator's judgment.
  • History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Treatment and study plan

Atogepant

Drug

Oral tablet

Other names: Qulipta, Aquipta

Placebo for Atogepant

Drug

Oral tablet

Primary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to approximately 16 weeks

    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.

  2. Change From Baseline in Mean Monthly Migraine Days

    Time frame: Baseline (Week 0) through Week 12

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

Secondary outcomes

  1. Change From Baseline in Mean Monthly Headache Days

    Time frame: Baseline (Week 0) through Week 12

    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.

  2. Change From Baseline in Mean Monthly Acute Medication Use Days

    Time frame: Baseline (Week 0) through Week 12

    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.

  3. Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days

    Time frame: Baseline (Week 0) through Week 12

    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.

  4. Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score

    Time frame: Baseline (Week 0) through Week 12

    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.

  5. Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score

    Time frame: Baseline (Week 0) through Week 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Feb 5, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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