A Phase 3 interventional study of Atogepant and Placebo for Atogepant in Migraine, sponsored by AbbVie. Completed at 149 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.
Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.
All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).
There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 2,158 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive both atogepant and placebo to treat qualifying migraines.
Drug: Atogepant · Drug: Placebo for Atogepant
Participants will receive both atogepant and placebo to treat qualifying migraines.
Drug: Atogepant · Drug: Placebo for Atogepant
Participants will receive both atogepant and placebo to treat qualifying migraines.
Drug: Atogepant · Drug: Placebo for Atogepant
Participants will receive both atogepant and placebo to treat qualifying migraines.
Drug: Atogepant · Drug: Placebo for Atogepant
Oral Tablet
Also known as: Qulipta, Aquipta
Oral Tablet
Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.
Time frame: Approximately 16 Weeks
Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) will be assessed.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack
Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack
Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack
Percentage of participants with use of rescue medication within 24 hours after the DB dose for the first attack will be assessed.
Time frame: Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack
Percentage of participants with ability to function normally at 2 hours after the DB dose for the first attack will be assessed.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack
Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack
Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack
Photophobia is defined as sensitivity to light.
Time frame: Approximately 16 Weeks
Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack
Phonophobia is defined as sensitivity to sound.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack
Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.
Time frame: Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack
Percentage of participants with ability to function normally at 8 hours after the DB dose for the first attack will be assessed.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack
Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.
Time frame: Approximately 16 Weeks
Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Percentage of participants with absence of nausea at 2 hours after the DB dose for the first attack.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack
Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.
Time frame: Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack
Percentage of participants with ability to function normally at 1 hour after the DB dose for the first attack will be assessed.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks
Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline \[predose\] to a mild headache or to no headache.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.
Time frame: Approximately 16 Weeks
Showing the first 100 of 149 sites across 15 countries.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie