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
- Registration Number
- NCT06810505
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
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History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
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During the last 28 days of the screening/baseline period, and as per eDiary:
- Participant must have completed the eDiary for a minimum of 20 out of 28 days.
- Participant has >= 15 headache days.
- Participant has >= 8 migraine days.
- Clinically significant hypertension per investigator's judgment.
- History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atogepant Atogepant Participants will receive atogepant once daily for 12 weeks. Placebo for Atogepant Placebo for Atogepant Participants will receive placebo for atogepant once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events (AEs) Up to approximately 16 weeks An adverse event (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.
Change From Baseline in Mean Monthly Migraine Days Baseline (Week 0) through Week 12 A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Headache Days 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.
Change From Baseline in Mean Monthly Acute Medication Use Days 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.
Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days 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.
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score 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.
Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score 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.
Related Research Topics
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Trial Locations
- Locations (25)
Rehabilitation & Neurological Services /ID# 270782
🇺🇸Huntsville, Alabama, United States
Preferred Research Partners /ID# 270389
🇺🇸Little Rock, Arkansas, United States
Neuro Pain Medical Center /ID# 271048
🇺🇸Fresno, California, United States
Excell Research /ID# 270258
🇺🇸Oceanside, California, United States
Sunwise Clinical Research /ID# 270431
🇺🇸Walnut Creek, California, United States
My Preferred Research /ID# 270312
🇺🇸Miami, Florida, United States
Deaconess Midtown Hospital /ID# 270572
🇺🇸Evansville, Indiana, United States
Cct Research - Papillion Research Center /ID# 270393
🇺🇸Papillion, Nebraska, United States
Healthy Perspectives - Innovate Mental Health Services /ID# 270847
🇺🇸Nashua, New Hampshire, United States
Frontier Clinical Research - Scottdale /ID# 270854
🇺🇸Scottdale, Pennsylvania, United States
Frontier Clinical Research - Smithfield /ID# 270849
🇺🇸Smithfield, Pennsylvania, United States
Access Clinical Trials Inc /ID# 270280
🇺🇸Nashville, Tennessee, United States
Earle Research /ID# 270424
🇺🇸Houston, Texas, United States
Clinpoint Trials /ID# 270261
🇺🇸Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 270259
🇺🇸Bountiful, Utah, United States
Highland Clinical Research /ID# 270281
🇺🇸Salt Lake City, Utah, United States
Frontier Clinical Research - Kingwood /ID# 271053
🇺🇸Kingwood, West Virginia, United States
Konan Medical Center /ID# 270486
🇯🇵Kobe-shi, Hyogo, Japan
Umenotsuji Clinic /ID# 270484
🇯🇵Kochi-shi, Kochi, Japan
Tominaga Clinic /ID# 270483
🇯🇵Osaka-shi, Osaka, Japan
Tokyo Headache Clinic /ID# 271610
🇯🇵Shibuya-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 270487
🇯🇵Shinjuku-ku, Tokyo, Japan
Tendo Brain Clinic /ID# 271410
🇯🇵Tendo-shi, Yamagata, Japan
Nagaseki Headache Clinic /ID# 271699
🇯🇵Kai, Yamanashi, Japan
Tanaka Neurosurgery & Headache Clinic /ID# 271346
🇯🇵Kagoshima, Japan