NCT05216263 (ATO-BOTOX) is a Phase 3 clinical trial of Atogepant in Chronic Migraine, sponsored by AbbVie.

Who is sponsoring NCT05216263?

NCT05216263 is sponsored by AbbVie.

What drugs are being tested in NCT05216263?

Interventions in NCT05216263: Atogepant.

What condition does NCT05216263 study?

NCT05216263 studies Chronic Migraine.

Is NCT05216263 still recruiting?

NCT05216263 is currently completed. Last updated 16 May 2025.

Last reviewed 2025-05-16 · How we verify

NCT05216263: ATO-BOTOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Completed Phase 3 Last updated 16 May 2025

What this trial tests

Phase 3 trial testing Atogepant in Chronic Migraine in 75 participants. Completed in 2 May 2025.

Timeline

22 March 2022

Primary endpoint
2 May 2025

2 May 2025

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	22 March 2022
Primary completion	2 May 2025
Estimated completion	2 May 2025
Sites	29 locations across United States

Drugs / interventions tested

Atogepant (ATOGEPANT) — full drug profile →

Conditions studied

Chronic Migraine — all drugs for Chronic Migraine →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. 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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Migraine: from pathophysiology to treatment.
Puledda F, Silva EM, Suwanlaong K, Goadsby PJ. · · 2023 · cited 99× · PMID 37029836 · DOI 10.1007/s00415-023-11706-1
Gepants - a long way to cure: a narrative review.
Altamura C, Brunelli N, Marcosano M, Fofi L, et al · · 2022 · cited 32× · PMID 35650458 · DOI 10.1007/s10072-022-06184-8
Atogepant: Mechanism of action, clinical and translational science.
Boinpally R, Shebley M, Trugman JM. · · 2024 · cited 16× · PMID 38266063 · DOI 10.1111/cts.13707
Atogepant for the prevention of episodic migraine in adults.
Switzer MP, Robinson JE, Joyner KR, Morgan KW. · · 2022 · cited 3× · PMID 36226229 · DOI 10.1177/20503121221128688
Update on gepants for the treatment of chronic migraine.
Aoh Y, Hou TW, Yang CC, Chang CM, et al · · 2024 · cited 2× · PMID 38349136 · DOI 10.1097/jcma.0000000000001070
Safety, tolerability, and efficacy of atogepant added to onabotulinumtoxinA for the preventive treatment of chronic migraine: A phase 3, multicenter, 24-week, open-label study.
Rothrock J, Najib U, Ailani J, Ashina S, et al · · 2026 · PMID 41944477 · DOI 10.1177/03331024261429118

Verify or expand the search:

Other trials of Atogepant

Trials testing the same drug.

NCT06136442 — Atogepant in Real Life in Italy (GIANT) · unknown
NCT05861427 — Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migrai · Phase 3 · completed
NCT05892757 — Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Fema · Phase 1 · completed
NCT05264129 — Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Par · Phase 4 · completed
NCT04829747 — Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Stu · Phase 3 · completed

Other recruiting trials for Chronic Migraine

Currently open trials in the same condition.

NCT06974617 — Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine · NA · recruiting
NCT06684249 — Efficacy of Nerve Block Versus Botox in Chronic Migraine Management · NA · recruiting
NCT05337033 — Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial · Phase 2 · recruiting
NCT06625060 — A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults · Phase 2 · recruiting
NCT06450444 — The RECLAIM Study. · NA · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05216263 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 16 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05216263.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing