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Purpose

A migraine is a 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Condition

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. - Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary. - To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria

  • History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). - Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). - Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs) 		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.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689
Experimental
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs) 		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.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689
Experimental
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs) 		Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689
Experimental
Double-Blind Treatment Period: Placebo (12-17 yrs) 		Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
  • Drug: Placebo-Matching Atogepant
    Oral Tablet
Experimental
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs) 		Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689
Experimental
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs) 		Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689
Experimental
Double-Blind Treatment Period: Placebo (6-11 yrs) 		Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
  • Drug: Placebo-Matching Atogepant
    Oral Tablet
Experimental
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs) 		Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
  • Drug: Atogepant
    Oral Tablet
    Other names:
    • QULIPTA
    • AGN-241689

Recruiting Locations

UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
Austin, Texas 78723-3079

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.