In short
Clinical trials are studying Atogepant in people with migraine, including adults and children. These studies look at how well it works, how safe it is, and how well people tolerate it for prevention or acute treatment. The trials include menstrual migraine, episodic migraine, chronic migraine, and pediatric migraine.
Key points
- Clinical trials of Atogepant are focused on migraine, including menstrual migraine, episodic migraine, chronic migraine, and migraine in children and teens. All of the listed studies are Phase 3 trials, which means they test the treatment in larger groups of people. One study looks at Atogepant for acute treatment of a single migraine attack, while most studies look at prevention. The trials include both placebo-controlled studies and a comparison with topiramate in adults. Main results being measured include migraine days, pain freedom, safety, tolerability, and reasons for stopping treatment.
Clinical trial overview
The trial program for Atogepant focuses on migraine in different patient groups, including adults, children, and teens.
All listed studies are Phase 3 trials, which means they are later-stage studies that test how well a treatment works and how safe it is in larger groups of people.
Most of the studies are testing preventive treatment, while one study is testing Atogepant for the acute treatment of a single migraine attack.
Menstrual migraine study
One authorized Phase 3 study is evaluating Atogepant for the preventive treatment of menstrual migraine in 448 participants.
This study compares Atogepant with placebo and looks at the change in the number of migraine days during the perimenstrual period, which means the time around a menstrual period.
The main outcome is measured across 3 menstrual cycles during the double-blind period, where neither participants nor study staff know which treatment is being given.
Acute migraine treatment study
The ECLIPSE study is a Phase 3, randomized, double-blind, placebo-controlled trial in 1,785 participants with migraine.
It is studying Atogepant as a single-dose treatment for one migraine attack, with an open-label extension afterward, which means some participants may later know they are taking the study drug.
The main endpoint is pain freedom at 2 hours after the dose for the first attack, meaning the headache changes from moderate or severe pain to no pain.
Pediatric migraine studies
Two Phase 3 studies are focused on children and teens with migraine.
One long-term extension study includes participants 6 to 17 years of age and is designed to assess safety and tolerability over time in 586 pediatric participants.
This study tracks adverse events, lab tests, ECG results, vital signs, suicidal thoughts or behavior, menstrual cycle assessments in female participants, Tanner stage, and BRIEF2 results, which help assess behavior and executive function, meaning planning and self-control skills.
Another pediatric study includes 450 participants aged 6 to 17 years with episodic migraine and measures the change in mean monthly migraine days over a 12-week treatment period.
A separate pediatric study in chronic migraine includes participants 12 to 17 years of age and looks at safety and efficacy in 426 participants.
Adult comparison with topiramate
The TEMPLE study is a Phase 3 trial in 520 adult participants with chronic and episodic migraine.
It compares Atogepant with topiramate, another migraine preventive treatment, to see how often participants stop treatment because of adverse events during a 24-week double-blind period.
This study is especially focused on tolerability, meaning whether people can stay on treatment without stopping because of unwanted medical problems.
Long-term prevention study
One completed Phase 3 open-label study examined Atogepant 60 mg once daily for up to 156 weeks in 596 participants with chronic or episodic migraine, including migraine without aura, migraine with aura, and chronic migraine.
The main outcome was the percentage of participants with at least one treatment-emergent adverse event, which means a medical problem that started or got worse after treatment began.
Because the study was open-label, participants knew what treatment they were receiving.
Main trial outcomes
Across the studies, the main outcomes include changes in migraine days, pain freedom, adverse events, and treatment discontinuation because of side effects.
The pediatric studies also add growth, puberty, heart rhythm, lab, and behavior measures, showing that the research is not only about migraine control but also about long-term safety in younger patients.