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A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2025-02-13
View on ClinicalTrials.gov ↗
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.

Amendment record

Amended 56 times since 2025-01-31; most recent filed 2026-08-20. The 50 most recent of 57 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-20
Amendment Study Status, Contacts/Locations v56
2026-07-13
Amendment Study Status, Contacts/Locations v55
2026-06-02
Amendment Study Status, Contacts/Locations v54
2026-05-21
Amendment Study Status, Contacts/Locations v53
2026-05-18
Amendment Study Status, Contacts/Locations v52
2026-05-11
Amendment Study Status v51
2026-04-13
Amendment Study Status, Contacts/Locations v50
2026-04-08
Amendment Study Status v49
2026-04-02
Amendment Study Status, Contacts/Locations v48
2026-04-01
Amendment Study Status v47
2026-03-31
Amendment Study Identification, Study Status, Contacts/Locations v46
2026-02-10
Amendment Study Status, Contacts/Locations v45
2026-02-03
Amendment Study Status, Contacts/Locations v44
2025-12-22
Amendment Study Status v43
2025-12-20
Amendment Study Status v42
2025-12-13
Amendment Study Status, Contacts/Locations v41
2025-11-05
Amendment Study Status, Contacts/Locations v40
2025-10-31
Amendment Study Status v39
2025-10-27
Amendment Study Status, Contacts/Locations v38
2025-09-25
Amendment Study Status, Contacts/Locations v37
2025-09-16
Amendment Study Status, Contacts/Locations v36
2025-09-02
Amendment Study Status, Contacts/Locations v35
2025-08-26
Amendment Study Identification, Study Status, Oversight, Contacts/Locations v34
2025-07-24
Amendment Study Status, Contacts/Locations v33
2025-07-22
Amendment Study Status, Contacts/Locations v32
2025-07-16
Amendment Study Status, Contacts/Locations v31
2025-07-11
Amendment Study Status, Contacts/Locations v30
2025-07-10
Amendment Study Status, Contacts/Locations v29
2025-07-08
Amendment Study Status, Contacts/Locations v28
2025-07-03
Amendment Study Status, Contacts/Locations v27
2025-07-01
Amendment Study Status, Contacts/Locations v26
2025-06-30
Amendment Study Status, Contacts/Locations v25
2025-06-26
Amendment Study Status, Contacts/Locations v24
2025-06-19
Amendment Study Status, Contacts/Locations v23
2025-06-12
Amendment Study Status, Contacts/Locations v22
2025-06-05
Amendment Study Status, Contacts/Locations v21
2025-05-28
Amendment Study Status, Contacts/Locations v20
2025-05-16
Amendment Study Status, Contacts/Locations v19
2025-05-15
Amendment Study Status, Contacts/Locations v18
2025-05-08
Amendment Study Status v17
2025-05-05
Amendment Study Status, Contacts/Locations v16
2025-04-30
Amendment Study Status, Contacts/Locations v15
2025-04-22
Amendment Study Status, Contacts/Locations v14
2025-04-18
Amendment Study Status, Contacts/Locations v13
2025-04-17
Amendment Study Status, Contacts/Locations v12
2025-04-15
Amendment Study Status, Contacts/Locations v11
2025-04-14
Amendment Study Status, Contacts/Locations v10
2025-04-10
Amendment Study Status, Contacts/Locations v9
2025-04-08
Amendment Study Status, Contacts/Locations v8
2025-04-07
Amendment Study Status, Contacts/Locations v7
Trial Details
NCT Number NCT06810505
Lead Sponsor AbbVie
Conditions Chronic Migraine
Enrollment 420 participants
Start Date 2025-02-13
Primary Completion 2031-03 (estimated)
Study Completion 2031-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-03