NCT03230864

Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)

Detailed description

In the study, patients will receive risperidone (4-6 mg/day), or, if recently failed on risperidone, olanzapine (15-20mg/day). Later during the study, patients will be randomized to either receive Lu AF35700 (10 mg/day), or continue their treatment from the prospective confirmation (PC) period. The study consists of a Screening Period (up to 3 weeks), a single-blind PC Period (6 weeks), a Double-blind Treatment (DBT) Period (8 weeks), and a Safety Follow-up Period (6 weeks). Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT period and were randomized into one of the 2 treatmetn arms (1:1) with either Lu AF35700 10 mg or to continue the treatment allocated in the PC period (olanzapine or risperidone) at the dose set at the last visit of the PC period. This means that approximately half of the confirmed treatment-resistant patients were randomised back to the failed treatment in the PC period. Data was not collected seperately for the DBT olanzapine and DBT risperidone participants, and there was no intent to compare Lu AF35700 to each drug seperately.

Conditions

• Treatment-resistant Schizophrenia

Interventions

Type	Name	Description
DRUG	Lu AF35700	10 mg/day, encapsulated tablets, orally
DRUG	Risperidone	4-6 mg/day, encapsulated tablets, orally
DRUG	Olanzapine	15-20 mg/day, encapsulated tablets, orally

Timeline

• Start date: 2017-07-20
• Primary completion: 2018-12-23
• Completion: 2019-02-05
• First posted: 2017-07-27
• Last updated: 2020-01-21
• Results posted: 2020-01-07

Locations

41 sites across 5 countries: United States, Bulgaria, Japan, Russia, United Kingdom

Regulatory

• FDA-regulated drug study