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

Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Rehabilitation & Neurological Services /ID# 270782
RECRUITING
Huntsville
Arkansas
Preferred Research Partner, Inc /ID# 270389
RECRUITING
Little Rock
Preferred Research Partners /ID# 270419
RECRUITING
Little Rock
California
Advanced Research Center /ID# 270257
RECRUITING
Anaheim
Neuro Pain Medical Center /ID# 271048
RECRUITING
Fresno
Accellacare - Long Beach /ID# 270398
RECRUITING
Long Beach
Excell Research /ID# 270258
RECRUITING
Oceanside
Sunwise Clinical Research /ID# 270431
RECRUITING
Walnut Creek
Florida
Northwest Florida Clinical Research Group, LLC /ID# 270833
RECRUITING
Gulf Breeze
Auzmer Research /ID# 271158
RECRUITING
Lakeland
My Preferred Research /ID# 270312
RECRUITING
Miami
Encore Medical Research - Weston /ID# 271139
RECRUITING
Weston
Indiana
Deaconess Midtown Hospital /ID# 270572
RECRUITING
Evansville
Michigan
Michigan Headache & Neurological Institute /ID# 270942
RECRUITING
Ann Arbor
Mississippi
Proven Endpoints LLC /ID# 270269
RECRUITING
Ridgeland
North Carolina
Headache Wellness Center /ID# 270568
RECRUITING
Greensboro
Nebraska
Cct Research - Papillion Research Center /ID# 270393
RECRUITING
Papillion
New Hampshire
Healthy Perspectives - Innovate Mental Health Services /ID# 270847
RECRUITING
Nashua
New York
Dent Neurologic Institute - Amherst /ID# 270260
RECRUITING
Amherst
Pennsylvania
Frontier Clinical Research - Scottdale /ID# 270854
RECRUITING
Scottdale
Frontier Clinical Research - Smithfield /ID# 270849
RECRUITING
Smithfield
Tennessee
Access Clinical Trials Inc /ID# 270280
RECRUITING
Nashville
Texas
Earle Research /ID# 270424
RECRUITING
Houston
Clinpoint Trials /ID# 270261
RECRUITING
Waxahachie
Utah
Pantheon Clinical Research /ID# 270259
RECRUITING
Bountiful
Highland Clinical Research /ID# 270281
RECRUITING
Salt Lake City
West Virginia
Frontier Clinical Research - Kingwood /ID# 271053
RECRUITING
Kingwood
Other Locations
Canada
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
RECRUITING
London
McGill University Health Centre - Glen Site /ID# 270662
RECRUITING
Montreal
Denmark
Herlev Hospital /ID# 270482
RECRUITING
Herlev
Regionshospitalet Godstrup /ID# 270481
RECRUITING
Herning
Hungary
Semmelweis Egyetem /ID# 271219
RECRUITING
Budapest
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
RECRUITING
Milan
Japan
Tanaka Neurosurgery & Headache Clinic /ID# 271346
RECRUITING
Kagoshima
Nagaseki Headache Clinic /ID# 271699
RECRUITING
Kai
Konan Medical Center /ID# 270486
RECRUITING
Kobe
Umenotsuji Clinic /ID# 270484
RECRUITING
Kochi
Tominaga Clinic - Osaka /ID# 270483
RECRUITING
Osaka
Tokyo Headache Clinic /ID# 271610
RECRUITING
Shibuya-ku
Tokyo Medical University Hospital /ID# 270487
RECRUITING
Shinjuku-ku
Tendo Brain Clinic /ID# 271410
RECRUITING
Tendo-shi
Netherlands
Canisius-Wilhelmina Ziekenhuis /ID# 270374
RECRUITING
Nijmegen
HagaZiekenhuis /ID# 270379
RECRUITING
The Hague
Poland
Athleticomed Sp. z o.o /ID# 270243
RECRUITING
Bydgoszcz
Specjalistyczne Gabinety Sp. z o.o /ID# 270238
RECRUITING
Krakow
Clinical Research Center Medic-R /ID# 270235
RECRUITING
Poznan
OHA-MED sp. z o.o /ID# 270242
RECRUITING
Warsaw
MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
RECRUITING
Wroclaw
Puerto Rico
Caribbean Medical Research Center /ID# 271300
RECRUITING
San Juan
United Kingdom
Royal Aberdeen Children's Hospital /ID# 271664
RECRUITING
Aberdeen
Medway Maritime Hospital /ID# 271885
RECRUITING
Gillingham
Stockport NHS Foundation Trust /ID# 271883
RECRUITING
Stockport
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2031-03
Participants
Target number of participants: 420
Treatments
Experimental: Atogepant
Participants will receive atogepant once daily for 12 weeks.
Placebo_comparator: Placebo for Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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