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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 Sex
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
Placebo Comparator
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
Placebo Comparator
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

Rehabilitation & Neurological Services /ID# 248517
Huntsville, Alabama 35805-4046

The Center for Clinical Trials - Saraland /ID# 271604
Saraland, Alabama 36571

Preferred Research Partners /ID# 249729
Little Rock, Arkansas 72211

Advanced Research Center /ID# 251381
Anaheim, California 92805

Alliance for Research Alliance for Wellness /ID# 248521
Long Beach, California 90807

Excell Research, Inc /ID# 247532
Oceanside, California 92056
Contact:
Site Coordinator
760-758-2222

Lumos Clinical Research Center /ID# 249731
San Jose, California 95124-4108

Sunwise Clinical Research /ID# 248529
Walnut Creek, California 94596

Northwest Florida Clinical Research Group, LLC /ID# 251382
Gulf Breeze, Florida 32561-4495
Contact:
Site Coordinator
850.934.1299

My Preferred Research LLC /ID# 249720
Miami, Florida 33155

Coastal Georgia Child Neurology /ID# 249733
Brunswick, Georgia 31520-1601
Contact:
Site Coordinator
770-376-7912

Deaconess Clinic - Gateway Health Center /ID# 247589
Newburgh, Indiana 47630
Contact:
Site Coordinator
812-474-7184

Michigan Headache & Neurological Institute (MHNI) /ID# 247468
Ann Arbor, Michigan 48104-5131
Contact:
Site Coordinator
734-677-6000

Proven Endpoints LLC /ID# 258066
Ridgeland, Mississippi 39157
Contact:
Site Coordinator
601-790-1811

Goryeb Childrens Hospital /ID# 249724
Morristown, New Jersey 07960

Dent Neurologic Institute - Amherst /ID# 248534
Amherst, New York 14226
Contact:
Site Coordinator
716-558-5670

Headache Wellness Center /ID# 251018
Greensboro, North Carolina 27405

Patient Priority Clinical Sites, LLC /ID# 247535
Cincinnati, Ohio 45215-2123
Contact:
Site Coordinator
513-791-7760

Cincinnati Childrens Hospital Medical Center /ID# 258070
Cincinnati, Ohio 45229

Lynn Institute of Oklahoma City /ID# 247600
Oklahoma City, Oklahoma 73112
Contact:
Site Coordinator
405-447-8839

Children's Hospital of Philadelphia - Main /ID# 258071
Philadelphia, Pennsylvania 19104-4319

Access Clinical Trials, Inc. /ID# 248532
Nashville, Tennessee 37203

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

FutureSearch Trials of Neurology /ID# 247470
Austin, Texas 78731

3A Research - East El Paso /ID# 248516
El Paso, Texas 79925-7945
Contact:
Site Coordinator
915-598-8888

Earle Research /ID# 248501
Friendswood, Texas 77546
Contact:
Site Coordinator
281-218-8080

ClinPoint Trials /ID# 248540
Waxahachie, Texas 75165-1430

Pantheon Clinical Research /ID# 251601
Bountiful, Utah 84010-4968

Alpine Research Organization - Clinton /ID# 276497
Clinton, Utah 84015

Highland Clinical Research /ID# 247590
Salt Lake City, Utah 84124

Office of Maria Ona /ID# 249738
Franklin, Virginia 23851

Dr. Samuel Sanchez PSC /ID# 248495
Caguas, Puerto Rico 00727

Puerto Rico Health Institute /ID# 249741
Dorado, Puerto Rico 00646
Contact:
Site Coordinator
787-797-1049

Caribbean Medical Research Center Headlands /ID# 251634
San Juan, Puerto Rico 00918-3501

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.