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A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder

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

Latest Information Update: 25 Oct 2024

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At a glance

  • Drugs ALTO-100 (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Sponsors Alto Neuroscience

    • Most Recent Events

    • 22 Oct 2024 Primary endpoint (To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-sberg Depression Rating Scale (MADRS) total score.) has not been met.
    • 22 Oct 2024 Results presented in an Alto Neuroscience Inc Media Release.
    • 13 Aug 2024 According to an Alto Neuroscience Inc media release, In Jun 2024, Company completed a successful Type C meeting with the U.S. Food and Drug Administration (FDA), in which it sought feedback regarding the development of ALTO-100 using a memory-based marker for patient enrichment. In the meeting the U.S. FDA provided feedback regarding the ongoing Phase 2b study suggesting the results from the study would provide further clarity on the registrational path for ALTO-100

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