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Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

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Trial Profile

Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2022

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At a glance

  • Drugs LU AF-35700 (Primary) ; Olanzapine; Risperidone
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms DayBreak; DAYBREAK I
  • Sponsors Lundbeck A/S

Most Recent Events

  • 01 Oct 2022 Results (n=1628) assessing efficacy and safety (NCT02717195 followed by a one year open-label safety extension NCT0289242) of Lu AF35700 in patients with treatment-resistant schizophrenia, published in the Schizophrenia Research.
  • 25 Oct 2018 Results presented in the Lundbeck media release.
  • 25 Oct 2018 Primary endpoint has not been met. (Change from randomisation to Week 10 of the double-blind treatment period in PANSS total score), according to a Lundbeck media release.

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