A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine (ATO EM PEDS)

June 10, 2026 updated by: AbbVie

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

A migraine is a 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Uza /Id# 247339
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, Belgium, 8000
        • Recruiting
        • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital /ID# 249672
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Center- University Hospital /ID# 252979
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre - Glen Site. /ID# 247271
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev Hospital /ID# 247724
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Recruiting
        • Regionshospitalet Godstrup /ID# 247902
        • Contact:
          • Site Coordinator
          • Phone Number: +45 50935730
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Sygehus Nord /ID# 247428
  • France
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse - Hôpital des enfants /ID# 247553
    • Somme
      • Amiens, Somme, France, 80054
        • Completed
        • CHU Amiens-Picardie Site Sud /ID# 248833
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Recruiting
        • Centre Hosp Intercommunal de Creteil /ID# 248832
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem /ID# 248360
      • Budapest, Hungary, 1024
        • Completed
        • MIND Clinic /ID# 248687
  • Israel
      • Haifa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center /ID# 247469
    • Central District
      • Beer Ya'akov, Central District, Israel, 70300
        • Recruiting
        • Shamir Medical Center /ID# 256857
    • Haifa District
      • Hadera, Haifa District, Israel, 38100
        • Completed
        • Hillel Yaffe Medical Center /ID# 246747
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 246746
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 247466
  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
    • Milano
      • Milan, Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù /ID# 247647
  • Japan
      • Kyoto, Japan, 600-8811
        • Recruiting
        • Tatsuoka Neurology Clinic /ID# 254455
    • Hyōgo
      • Kobe, Hyōgo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center /ID# 254457
      • Nishinomiya, Hyōgo, Japan, 663-8204
        • Recruiting
        • Yamaguchi Clinic /ID# 254753
    • Kochi
      • Kochi, Kochi, Japan, 780-8011
        • Recruiting
        • Umenotsuji Clinic /ID# 254453
    • Miyagi
      • Sendai, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
    • Osaka
      • Osaka, Osaka, Japan, 556-0015
        • Recruiting
        • Tominaga Clinic - Osaka /ID# 254450
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 254459
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Recruiting
        • Canisius-Wilhelmina Ziekenhuis /ID# 253065
    • South Holland
      • The Hague, South Holland, Netherlands, 2545AA
        • Recruiting
        • HagaZiekenhuis /ID# 247318
    • Zeeland
      • Terneuzen, Zeeland, Netherlands, 4535 PA
        • Recruiting
        • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
  • Poland
      • Wroclaw, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-848
        • Recruiting
        • Clinical Research Center Medic-R /ID# 247383
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
        • Recruiting
        • Athleticomed Sp. z o.o /ID# 248789
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-539
        • Recruiting
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • Recruiting
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-018
        • Recruiting
        • Oha-Med Sp. Z O.O /ID# 248614
  • Puerto Rico
      • Bayamón, Puerto Rico, 00960
        • Completed
        • Clinical Research Investigator Group /ID# 261254
      • Caguas, Puerto Rico, 00727
        • Recruiting
        • Dr. Samuel Sanchez PSC /ID# 248495
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute /ID# 249741
        • Contact:
          • Site Coordinator
          • Phone Number: 787-797-1049
      • San Juan, Puerto Rico, 00918-3501
        • Recruiting
        • CMRC Headlands LLC /ID# 251634
      • San Juan, Puerto Rico, 00927
        • Completed
        • PRCCI Clinical Research Center /ID# 262726
  • Romania
      • Bucharest, Romania, 014146
        • Completed
        • Delta Health Care S.R.L /ID# 248130
    • Bucharest
      • Bucharest, Bucharest, Romania, 022102
        • Completed
        • Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400012
        • Completed
        • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall de Hebron /ID# 247967
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos /ID# 249267
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre /ID# 275578
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio /ID# 248632
      • Valencia, Spain, 46026
        • Completed
        • Hospital Universitario y Politecnico La Fe /ID# 247969
  • Sweden
      • Mölnlycke, Sweden, 435 30
        • Recruiting
        • Vastra Gotealandsregionen Regionhalsan /ID# 248277
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 118 83
        • Recruiting
        • Sodersjukhuset /ID# 248279
  • United Kingdom
      • Aberdeen, United Kingdom, AB15 6RE
        • Recruiting
        • NHS Grampian /ID# 249067
      • Stockport, United Kingdom, SK2 7JE
        • Recruiting
        • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
    • Greater London
      • London, Greater London, United Kingdom, WC1N 3HZ
        • Recruiting
        • Great Ormond Street Children's Hospital /ID# 262933
    • Kent
      • Gillingham, Kent, United Kingdom, ME7 5NY
        • Recruiting
        • Medway NHS Foundation Trust /ID# 249065
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-4046
        • Recruiting
        • Rehabilitation & Neurological Services /ID# 248517
      • Saraland, Alabama, United States, 36571
        • Recruiting
        • The Center for Clinical Trials - Saraland /ID# 271604
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners /ID# 249729
      • Little Rock, Arkansas, United States, 72211
        • Completed
        • Preferred Research Partners /ID# 270406
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center /ID# 251381
      • Long Beach, California, United States, 90807
        • Recruiting
        • Alliance for Research Alliance for Wellness /ID# 248521
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc /ID# 247532
        • Contact:
          • Site Coordinator
          • Phone Number: 760-758-2222
      • San Jose, California, United States, 95124-4108
        • Recruiting
        • Lumos Clinical Research Center /ID# 249731
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research /ID# 248529
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Completed
        • Advanced Neurosciences Research, LLC /ID# 247592
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4495
        • Recruiting
        • Northwest Florida Clinical Research Group, LLC /ID# 251382
        • Contact:
          • Site Coordinator
          • Phone Number: 850.934.1299
      • Homestead, Florida, United States, 33030-4613
        • Completed
        • Advanced Research Institute of Miami /ID# 248539
      • Miami, Florida, United States, 33155
        • Recruiting
        • My Preferred Research LLC /ID# 249720
      • Spring Hill, Florida, United States, 34609-5692
        • Completed
        • Asclepes Research Centers - Spring Hill /ID# 248525
    • Georgia
      • Brunswick, Georgia, United States, 31520-1601
        • Recruiting
        • Coastal Georgia Child Neurology /ID# 249733
        • Contact:
          • Site Coordinator
          • Phone Number: 770-376-7912
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • Deaconess Clinic - Gateway Health Center /ID# 247589
        • Contact:
          • Site Coordinator
          • Phone Number: 812-474-7184
    • Kansas
      • Overland Park, Kansas, United States, 66210-2761
        • Completed
        • College Park Family Care Center Overland Park /ID# 249734
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Recruiting
        • Michigan Headache & Neurological Institute (MHNI) /ID# 247468
        • Contact:
          • Site Coordinator
          • Phone Number: 734-677-6000
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • Proven Endpoints LLC /ID# 258066
        • Contact:
          • Site Coordinator
          • Phone Number: 601-790-1811
    • Nebraska
      • Papillion, Nebraska, United States, 68046-4131
        • Recruiting
        • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
        • Contact:
          • Site Coordinator
          • Phone Number: 402-979-8770
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Childrens Hospital /ID# 249724
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute - Amherst /ID# 248534
        • Contact:
          • Site Coordinator
          • Phone Number: 716-558-5670
      • New York, New York, United States, 10001
        • Completed
        • Modern Migraine MD /ID# 258074
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center /ID# 251018
    • Ohio
      • Cincinnati, Ohio, United States, 45215-2123
        • Recruiting
        • Patient Priority Clinical Sites, LLC /ID# 247535
        • Contact:
          • Site Coordinator
          • Phone Number: 513-791-7760
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center /ID# 258070
      • West Chester, Ohio, United States, 45069
        • Completed
        • CincyScience /ID# 249726
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Lynn Institute of Oklahoma City /ID# 247600
        • Contact:
          • Site Coordinator
          • Phone Number: 405-447-8839
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4319
        • Recruiting
        • Children's Hospital of Philadelphia - Main /ID# 258071
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital /ID# 261084
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Access Clinical Trials, Inc. /ID# 248532
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology /ID# 247470
      • Austin, Texas, United States, 78723-3079
        • Recruiting
        • UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
      • El Paso, Texas, United States, 79925-7945
        • Recruiting
        • 3A Research - East El Paso /ID# 248516
        • Contact:
          • Site Coordinator
          • Phone Number: 915-598-8888
      • Friendswood, Texas, United States, 77546
        • Recruiting
        • Earle Research /ID# 248501
        • Contact:
          • Site Coordinator
          • Phone Number: 281-218-8080
      • The Woodlands, Texas, United States, 77381
        • Completed
        • Family Psychiatry of The Woodlands /ID# 249727
      • Waxahachie, Texas, United States, 75165-1430
        • Recruiting
        • ClinPoint Trials /ID# 248540
    • Utah
      • Bountiful, Utah, United States, 84010-4968
        • Recruiting
        • Pantheon Clinical Research /ID# 251601
        • Contact:
          • Site Coordinator
          • Phone Number: 385-281-8351
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization - Clinton /ID# 276497
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Highland Clinical Research /ID# 247590
    • Virginia
      • Franklin, Virginia, United States, 23851
        • Recruiting
        • Office of Maria Ona /ID# 249738
    • Washington
      • Everett, Washington, United States, 98201
        • Completed
        • Core Clinical Research /ID# 249721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
  • History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
  • Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
  • To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria:

  • History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Placebo Comparator: Double-Blind Treatment Period: Placebo (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Drug: Placebo-Matching Atogepant
Oral Tablet
Placebo Comparator: Double-Blind Treatment Period: Placebo (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Drug: Placebo-Matching Atogepant
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mean Monthly Migraine Days
Time Frame: Baseline (Week 0) through Week 12
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Baseline (Week 0) through Week 12
Number of Participants Experiencing Adverse Events
Time Frame: Baseline (Week 0) through Week 16
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Baseline (Week 0) through Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mean Monthly Headache Days
Time Frame: Baseline (Week 0) through Week 12
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Baseline (Week 0) through Week 12
Change from Baseline in Mean Monthly Acute Medication Use Days
Time Frame: Baseline (Week 0) through Week 12
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Baseline (Week 0) through Week 12
Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days
Time Frame: Baseline (Week 0) to 3 Months
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Baseline (Week 0) to 3 Months
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
Time Frame: Baseline (Week 0) through Week 12
The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.
Baseline (Week 0) through Week 12
Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score
Time Frame: Baseline (Week 0) through Week 12
The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.
Baseline (Week 0) through Week 12
Change from Baseline in Mean Monthly Headache Days of at Least Moderate Severity
Time Frame: Baseline (Week 0) through Week 12
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Baseline (Week 0) through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-201
  • 2022-501100-94-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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