Atogepant for Chronic Migraine in Teens Aged 12 to 17
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
Recruiting
Phase 3Interventional Study
Chronic Migraine
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for teenagers aged 12 to 17 who have chronic migraines. Participants will take a daily tablet of either atogepant or a placebo for 12 weeks and will keep track of their headaches.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with chronic migraine for at least 6 months.
I have had at least 15 headache days in the last month.
I have had at least 8 migraine days in the last month.
I have completed a daily headache diary for at least 20 out of the last 28 days.
You may not be able to join if
I have high blood pressure as determined by my doctor.
I have a history of significant health problems in areas like blood, lungs, or heart.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
* During the last 28 days of the screening/baseline period, and as…
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* Clinically significant hypertension per investigator's judgment.
* History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
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