atogepant
atogepant: developed by 1 company · 10 clinical trials tracked · 1 FDA decision.
atogepant evidence translation
What we can confirm
1 FDA record · 10 tracked trials
What it means
What to watch
Prepared research question
How could atogepant → ABBV affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| AbbVie Inc. (ABBV) Menstrual Migraine (MM); Chronic Migraine; Episodic Migraine | Phase 3 |
Clinical Trials (10)
A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study
Primary endpoint: Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
Primary endpoint: Number of Participants Experiencing Adverse Events (AEs)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine
Primary endpoint: Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period
Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients
Primary endpoint: Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)
Migraine Medication Effects on Urinary Symptoms
Primary endpoint: changes in OAB symptoms
Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
Primary endpoint: Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack
A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)
Primary endpoint: Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine
Primary endpoint: Change From Baseline in Mean Monthly Migraine Days
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
Primary endpoint: Change from Baseline in Mean Monthly Migraine Days
A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine
Primary endpoint: Number of Participants With Adverse Events (AEs)
Frequently asked questions
Who is developing atogepant?
atogepant is being developed by AbbVie Inc..
How many clinical trials involve atogepant?
BioSniper tracks 10 clinical trials involving atogepant.
What is atogepant's latest FDA decision?
The most recent tracked FDA decision for atogepant is Approval, dated September 28, 2021.