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A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

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A Phase 3, Double-blind, Randomized, Placebo-controlled, Multi-center, Fixed-dose, Parallel Group Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2024

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At a glance

  • Drugs Dexmethylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Cingulate Therapeutics

    • Most Recent Events

    • 15 Aug 2024 Status changed from active, no longer recruiting to discontinued.
    • 21 May 2024 According to a Cingulate Therapeutics media release, the company received the U.S. Food and Drug Administration (FDA) approval on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older,under the Section 505(b)(2) pathway.
    • 22 Jan 2024 Planned primary completion date changed from 1 Dec 2023 to 1 Jan 2024.

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