Using Atogepant tablets to prevent migraines in teens aged 12 to 17
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
This study is testing if Atogepant tablets can help prevent migraines in teenagers aged 12 to 17.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 61 sites (Huntsville, Alabama and 60 other locations) |
| Trial ID | NCT06810505 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of Atogepant, an oral medication, in preventing chronic migraines in adolescents aged 12 to 17 years. Participants will be randomly assigned to receive either Atogepant or a placebo, with neither the participants nor the researchers knowing which treatment is being administered (double-blind). The study aims to assess adverse events and changes in disease activity over the treatment period. It is designed to provide insights into how well Atogepant can reduce the frequency of migraine attacks in this age group.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 17 with a history of chronic migraines for at least 6 months.
Not a fit: Patients with significant hypertension or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraines in adolescents, improving their quality of life.
How similar studies have performed: Previous studies have shown positive results with Atogepant in adult populations, suggesting potential for success in younger patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Huntsville, Alabama and 60 other locations
- Rehabilitation & Neurological Services /ID# 270782 — Huntsville, Alabama, United States (Recruiting)
- Preferred Research Partner, Inc /ID# 270389 — Little Rock, Arkansas, United States (Recruiting)
- Preferred Research Partners /ID# 270419 — Little Rock, Arkansas, United States (Completed)
- Advanced Research Center /ID# 270257 — Anaheim, California, United States (Recruiting)
- Neuro Pain Research Center /ID# 271048 — Fresno, California, United States (Recruiting)
- Accellacare - Long Beach /ID# 270398 — Long Beach, California, United States (Recruiting)
- Excell Research /ID# 270258 — Oceanside, California, United States (Recruiting)
- Lumos Clinical Research Center /ID# 270582 — San Jose, California, United States (Recruiting)
- Sunwise Clinical Research /ID# 270431 — Walnut Creek, California, United States (Recruiting)
- Northwest Florida Clinical Research Group, LLC /ID# 270833 — Gulf Breeze, Florida, United States (Recruiting)
- Auzmer Research /ID# 271158 — Lakeland, Florida, United States (Completed)
- My Preferred Research /ID# 270312 — Miami, Florida, United States (Recruiting)
- Encore Medical Research - Weston /ID# 271139 — Weston, Florida, United States (Recruiting)
- Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 — Winter Park, Florida, United States (Recruiting)
- Deaconess Midtown Hospital /ID# 270572 — Evansville, Indiana, United States (Recruiting)
- Michigan Headache & Neurological Institute /ID# 270942 — Ann Arbor, Michigan, United States (Recruiting)
- Proven Endpoints LLC /ID# 270269 — Ridgeland, Mississippi, United States (Recruiting)
- Cct Research - Papillion Research Center /ID# 270393 — Papillion, Nebraska, United States (Recruiting)
- Healthy Perspectives - Innovate Mental Health Services /ID# 270847 — Nashua, New Hampshire, United States (Recruiting)
- Dent Neurologic Institute - Amherst /ID# 270260 — Amherst, New York, United States (Recruiting)
- Headache Wellness Center /ID# 270568 — Greensboro, North Carolina, United States (Recruiting)
- Frontier Clinical Research - Scottdale /ID# 270854 — Scottdale, Pennsylvania, United States (Recruiting)
- Frontier Clinical Research - Smithfield /ID# 270849 — Smithfield, Pennsylvania, United States (Recruiting)
- Access Clinical Trials Inc /ID# 270280 — Nashville, Tennessee, United States (Recruiting)
- UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577 — Austin, Texas, United States (Recruiting)
- Earle Research /ID# 270424 — Houston, Texas, United States (Recruiting)
- Clinpoint Trials /ID# 270261 — Waxahachie, Texas, United States (Recruiting)
- Pantheon Clinical Research /ID# 270259 — Bountiful, Utah, United States (Recruiting)
- Alpine Research Organization - Clinton /ID# 276527 — Clinton, Utah, United States (Recruiting)
- Highland Clinical Research /ID# 270281 — Salt Lake City, Utah, United States (Recruiting)
- Frontier Clinical Research - Kingwood /ID# 271053 — Kingwood, West Virginia, United States (Recruiting)
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659 — London, Ontario, Canada (Recruiting)
- McGill University Health Centre - Glen Site. /ID# 270662 — Montreal, Quebec, Canada (Recruiting)
- Herlev Hospital /ID# 270482 — Herlev, Capital Region, Denmark (Recruiting)
- Regionshospitalet Godstrup /ID# 270481 — Herning, Central Jutland, Denmark (Recruiting)
- Semmelweis Egyetem /ID# 271219 — Budapest, Hungary (Recruiting)
- Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500 — Budapest, Hungary (Recruiting)
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756 — Milan, Milano, Italy (Recruiting)
- Ospedale Pediatrico Bambino Gesù /ID# 270759 — Rome, Roma, Italy (Recruiting)
- Konan Medical Center /ID# 270486 — Kobe, Hyōgo, Japan (Recruiting)
- Umenotsuji Clinic /ID# 270484 — Kochi, Kochi, Japan (Recruiting)
- Tominaga Clinic - Osaka /ID# 270483 — Osaka, Osaka, Japan (Recruiting)
- Tokyo Headache Clinic /ID# 271610 — Shibuya-ku, Tokyo, Japan (Recruiting)
- Tokyo Medical University Hospital /ID# 270487 — Shinjuku-ku, Tokyo, Japan (Recruiting)
- Tendo Brain Clinic /ID# 271410 — Tendo-shi, Yamagata, Japan (Recruiting)
- Nagaseki Headache Clinic /ID# 271699 — Kai, Yamanashi, Japan (Recruiting)
- Tanaka Neurosurgery & Headache Clinic /ID# 271346 — Kagoshima, Japan (Recruiting)
- Canisius-Wilhelmina Ziekenhuis /ID# 270374 — Nijmegen, Gelderland, Netherlands (Recruiting)
- HagaZiekenhuis /ID# 270379 — The Hague, South Holland, Netherlands (Recruiting)
- Clinical Research Center Medic-R /ID# 270235 — Poznan, Greater Poland Voivodeship, Poland (Recruiting)
+11 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.