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A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension

Trial Profile

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension

Status: Completed
Phase of Trial: Phase II

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, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Companys New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
    • 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.
    • 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.
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