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Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

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Trial Profile

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2025

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At a glance

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

Most Recent Events

  • 03 Jul 2024 Planned number of patients changed from 1200 to 1400.
  • 03 Jul 2024 Planned End Date changed from 1 Jun 2025 to 1 Sep 2026.
  • 03 Jul 2024 Planned primary completion date changed from 1 Jun 2025 to 1 Sep 2026.

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