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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2024

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At a glance

  • Drugs Roluperidone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Minerva Neurosciences

    • Most Recent Events

    • 27 Feb 2024 According to a Minerva Neurosciences media release, to address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms.
    • 27 Feb 2024 According to a Minerva Neurosciences media release, In the CRL, the FDA cited the following clinical deficiencies: The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
    • 27 Feb 2024 According to a Minerva Neurosciences media release, In the CRL, the FDA cited the following clinical deficiencies: Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness. The NDA submission lacks data on concomitant antipsychotic administration.

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