Axsome Therapeutics doses first pediatric adhd trial patient
- Axsome Therapeutics (NASDAQ:AXSM) dosed the first patient in its Phase 3 FOCUS-2 clinical trial evaluating solriamfetol in children with attention deficit hyperactivity disorder.
- The initiation of active pediatric testing broadens the clinical development pipeline for the central nervous system drug candidate.
- Axsome plans to leverage the study's safety and efficacy data to complement its ongoing adolescent trial and expand into the pediatric market.
Axsome Therapeutics (NASDAQ:AXSM) announced it dosed the first patient in its Phase 3 FOCUS-2 clinical trial evaluating solriamfetol as a potential treatment for children with attention deficit hyperactivity disorder.
The newly initiated trial expands the biopharmaceutical firm's active pediatric pipeline following the recent deployment of its companion FOCUS-3 study targeting adolescent patients.
"The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with ADHD," stated the central nervous system specialist in its clinical trial initialization bulletin.
The multi-center study will randomize its entire patient registry under a strict one-to-one-to-one ratio to receive one of two distinct active drug doses or a matching placebo.
The randomized, double-blind, placebo-controlled protocol evaluates the investigational dopamine and norepinephrine reuptake inhibitor over a fixed six-week treatment period.
The clinical investigators will track changes from baseline in the standardized ADHD Rating Scale total score as the study's primary efficacy endpoint.
