Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie has initiated a Phase 3 clinical study titled 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. The study aims to assess the safety and efficacy of Atogepant in preventing chronic migraines in adolescents, a significant step as migraines can severely impact quality of life.
The study tests Atogepant, an oral tablet already approved for adult migraine prevention, against a placebo. The goal is to determine its effectiveness in a younger demographic, potentially expanding its use.
This randomized, double-blind study involves 420 participants across 70 global sites. Participants will be divided into two groups, receiving either Atogepant or a placebo daily for 12 weeks, with a follow-up period of 4 weeks. The study employs a quadruple masking model to ensure unbiased results.
The study began on February 13, 2025, with primary completion expected in 2025. The last update was submitted on July 1, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
If successful, this study could positively impact AbbVie’s stock by expanding Atogepant’s market to include adolescents, potentially increasing revenue. It also positions AbbVie competitively in the migraine treatment market, which is continually evolving with new entrants.
The study is ongoing, with further details available on the ClinicalTrials portal.