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
Price :
$35
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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
- 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.