Axsome Therapeutics has dosed the first patient in its FOCUS-3 Phase III clinical trial assessing solriamfetol in adolescents with attention deficit hyperactivity disorder (ADHD).
The double-blind, randomised, multicentre, placebo-controlled trial will evaluate the efficacy and safety of solriamfetol in adolescents aged 12 to less than 18 years who have ADHD.
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It aims to enrol around 468 patients, randomly assigning them in 1:1:1 ratio to receive either one of two doses of solriamfetol or a placebo for six weeks.
The trial’s primary endpoint is the change from baseline to week six in the ADHD Rating Scale total score.
ADHD is a chronic neurobiological and developmental disorder impacting attention, hyperactivity and impulsivity, which can result in challenges with functioning and development.
Cognitive impairments are observed in attention, planning, problem solving, working memory and behavioural inhibition.
Solriamfetol functions as a dopamine and norepinephrine reuptake inhibitor, a trace amine-associated receptor 1 agonist and a 5-hydroxytryptamine 1a receptor agonist.
It is under development for several central nervous system disorders beyond ADHD, including major depressive disorder with excessive daytime sleepiness, binge eating disorder and excessive sleepiness tied to shift work disorder.
Earlier this year, Axsome Therapeutics initiated the FORWARD Phase III trial evaluating AXS-14 (esreboxetine) for the management of fibromyalgia, with the first patient dosed.
The FORWARD Phase III trial, using a randomised withdrawal research design, aims to assess the efficacy of AXS-14 in patients with fibromyalgia, a neurological pain disorder affecting around 17 million individuals in the US.
The company’s neuroscience portfolio includes treatments approved by the FDA for major depressive disorder and agitation associated with dementia due to Alzheimer’s disease, along with several new products for a range of complex neurological and psychiatric conditions.
