Trial Profile
A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Aug 2023
Price :
$35
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At a glance
- Drugs Dasotraline (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Sunovion Pharmaceuticals
- 13 May 2020 According to a Sunovion Pharmaceuticals Media Release, company has withdrawn the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of moderate-to-severe binge eating disorder (BED) and attention deficit hyperactivity disorder (ADHD).
- 10 Nov 2017 According to a Sunovion Pharmaceuticals Media Release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults, based on the data from multiple placebo-controlled safety and efficacy studies, as well as two long-term studies
- 21 Apr 2017 According to a Sunovion Pharmaceuticals media release, the full study results were presented at the 6th World Congress on ADHD.