🏛️ Verified NIH Record • Updated 2026-07-28

Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine (NCT06806293)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM. Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. 468 adult female participants with menstrual migraine are enrolled in approximately 92 sites across the world. Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Who can join: Review the eligibility criteria below.

Location: Premier Health - Centerville /ID# 267023 — Centerville, Ohio

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (95 Sites)

Showing the first 25 of 95 sites.

  • Premier Health - Centerville /ID# 267023 — Centerville, Ohio
  • Chinese PLA General Hospital /ID# 267141 — Beijing, Beijing Municipality
  • Nanfang Hospital - Southern Medical University /ID# 268510 — Guangzhou, Guangdong
  • Hebei General Hospital /ID# 267663 — Shijiazhuang, Hebei
  • Renmin Hospital of Wuhan University /ID# 267671 — Wuhan, Hubei
  • The First Affiliated Hospital of Soochow University /ID# 267885 — Suzhou, Jiangsu
  • Shaanxi Provincial PeopleS Hospital /ID# 267827 — Xi'an, Shaanxi
  • First Affiliated Hospital of Shanxi Medical University /ID# 267680 — Taiyuan, Shanxi
  • Tianjin Medical University General Hospital /ID# 268846 — Tianjin, Tianjin Municipality
  • Tianjin People's Hospital /ID# 268511 — Tianjin, Tianjin Municipality
  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994 — Hangzhou, Zhejiang
  • Minksneuro /ID# 267651 — Brno, Brno-mesto
  • A-Shine s.r.o. /ID# 266048 — Pilsen, Plzeň Region
  • Vseobecna Fakultni nemocnice v Praze /ID# 268100 — Prague, Praha 17
  • DADO MEDICAL s.r.o. /ID# 267629 — Prague, Praha 2
  • Neurologie Brno /ID# 266050 — Brno,
  • NeuroHK s.r.o. /ID# 266051 — Hradec Králové,
  • Neuro plus s.r.o. /ID# 266052 — Olomouc,
  • Clintrial s.r.o. /ID# 266047 — Prague,
  • Pratia Prague s.r.o. /ID# 268252 — Prague,
  • Fakultni Thomayerova nemocnice /ID# 266049 — Prague,
  • Neuro Centrum Odenwald - Praxis Erbach /ID# 276171 — Erbach im Odenwald, Hesse
  • Studienzentrum Nord-West /ID# 267311 — Westerstede, Lower Saxony
  • Universitaetsmedizin Greifswald /ID# 267277 — Greifswald, Mecklenburg-Vorpommern
  • Neurozentrum Bielefeld /ID# 276170 — Bielefeld, North Rhine-Westphalia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Menstrual Migraine (MM) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗