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Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

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Trial Profile

Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Molindone (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions
  • Acronyms CHIME 4
  • Sponsors Supernus Pharmaceuticals

Most Recent Events

  • 22 Apr 2024 Status changed from completed to discontinued.
  • 19 Oct 2020 Status changed from recruiting to completed.
  • 06 Aug 2019 According to Supernus media release, enrollment in this study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.7 months, which the company believes is an encouraging sign of the tolerability and efficacy of SPN-810.

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