Episodic migraine
Conditions
Interventions
Atogepant Oral Tablet or Placebo-Matching Atogepant Oral Tablet for 12 weeks
Sponsors
Otani Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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 persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018). Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through Week 12 ] | — |
Countries
Belgium, Canada, Denmark, France, Hungary, Israel, Italy, Japan, Netherlands, Poland, Puerto Rico, Romania, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactPatients and HCP Contact
AbbVie G.K.
Outcome results
None listed