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Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial

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Trial Profile

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2021

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At a glance

  • Drugs Viloxazine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Supernus Pharmaceuticals

    • Most Recent Events

    • 15 Sep 2021 Results of post-hoc analysis of four studies (NCT03247530, NCT03247517, NCT03247543 & NCT03247556) assessing the effect of viloxazine extended-release capsules on executive function deficits in pediatric subjects with attention-deficit/hyperactivity disorder published in the Pediatric Drugs.
    • 16 Jul 2021 Results (n=495) of data from four studies (NCT03247530, NCT03247543, NCT03247517 and NCT03247556) assessing development of PK model to describe the PK profile of viloxazine and its major metabolite 5-HVLX-gluc in pediatric individuals with ADHD, published in the Journal of Clinical Pharmacology
    • 10 May 2021 Results of post hoc pooled analysis assessing clinical relevance (benefits and tolerabilit) of NCT03247530, NCT03247543, NCT03247517 and NCT03247556, pivotal phase 3 trials in pediatric patients treated with viloxazine extended-release, published in the International Journal of Clinical Practice.

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