A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- BI 425809 dose 1
- Conditions
- Schizophrenia
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 509
- Locations
- 81
- Primary Endpoint
- Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 425809 dose 1
Intervention: BI 425809 dose 1
BI 425809 dose 1
Intervention: Placebo
BI 425809 dose 2
Intervention: BI 425809 dose 2
BI 425809 dose 2
Intervention: Placebo
BI 425809 dose 3
Intervention: BI 425809 dose 3
BI 425809 dose 3
Intervention: Placebo
BI 425809 dose 4
Intervention: BI 425809 dose 4
BI 425809 dose 4
Intervention: Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment
Time Frame: Baseline, after 6 and 12 weeks of treatment
MCCB overall composite T-score was derived from scores of 7 cognitive domains (Speed of Processing, Verbal Learning, Working Memory, Reasoning and Problem Solving, Visual Learning, Social Cognition, Attention) obtained from a total of 10 tests (Trail Making, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning, Wechsler Memory Scale, Letter-Number Span, Neuropsychological Assessment Battery, Brief Visuospatial Memory, Category Fluency, Mayer-Salovey-Caruso Emotional Intelligence, Continuous Performance) and ranges typically between -20 and +99, a larger T-score indicates better cognition. Change from baseline in MCCB overall composite T-score after 12 weeks of treatment was modeled using a MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (week 6 and week 12 of treatment) as repeated measures, subject as random effect, adjusted mean (standard error) after 12 weeks of treatment is reported.
Secondary Outcomes
- Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment(Baseline and after 12 weeks of treatment)
- Percentage of Participants With Any Adverse Event(On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days)