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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03859973
Registration number
NCT03859973
Ethics application status
Date submitted
25/02/2019
Date registered
1/03/2019
Date last updated
18/11/2023
Titles & IDs
Public title
This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
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Scientific title
A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia
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Secondary ID [1]
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2018-002740-82
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Secondary ID [2]
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1346-0038
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Condition category
Condition code
Mental Health
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 425809
Treatment: Drugs - Placebo
Experimental: BI 425809 10 mg + Computerized Cognitive Training -
Placebo Comparator: Placebo + Computerized Cognitive Training -
Treatment: Drugs: BI 425809
Tablet
Treatment: Drugs: Placebo
Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Neurocognitive Function as Measured by the Neurocognitive Composite Score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment
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Assessment method [1]
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MCCB neurocognitive composite T-score assesses 6 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving. MCCB neurocognitive T-scores in the general population have a mean of 50 and standard deviation of 10. A higher T-score indicates better cognition. Change from baseline in MCCB neurocognitive composite T-score at Week 12 was modelled based on a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.
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Timepoint [1]
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At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.
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Secondary outcome [1]
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Change From Baseline in Cognitive Function as Measured by the Overall MCCB Composite T Score (Including Social Cognition) After 12 Weeks of Treatment
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Assessment method [1]
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MCCB cognitive score comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. MCCB cognitive T-scores in the general population have a mean of 50 and standard deviation of 10. A higher T-score indicates better cognition. Change from baseline in MCCB overall composite T-score was modelled using a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.
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Timepoint [1]
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At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.
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Secondary outcome [2]
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Change From Baseline in the Effect of Cognitive Deficit on Day-to-day Functioning as Measured by SCoRS Total Score After 12 Weeks of Treatment
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Assessment method [2]
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Schizophrenia Cognition Rating Scale (SCoRS) is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. The composite score was the average of non-missing responses. If five or more of the 20 items were missing, the composite score was missing for that participant at the visit.
Change from baseline in SCoRS total score after 12 weeks of treatment was modelled using an Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.
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Timepoint [2]
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At baseline and at 12 weeks after first drug administration.
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Secondary outcome [3]
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After 12 Weeks of Treatment
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Assessment method [3]
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PANSS was used to evaluate broad psychopathology associated with schizophrenia disease state. The PANSS has 30 items. Each is rated from 1 to 7 points. The total factor score is the summation of the actual points for each item, leading the total score ranging from 30 to 210; a higher score indicates a worse disease condition.
Change from baseline in PANNS total score after 12 weeks of treatment was modelled based on a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.
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Timepoint [3]
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At baseline and at Weeks 6 and 12 after first drug administration.
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Secondary outcome [4]
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Percentage of Patients With Any Adverse Event (AE) and With Serious Adverse Events (SAEs)
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Assessment method [4]
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Percentage of patients with any Adverse Event (AE) and with serious adverse events (SAEs) is reported.
Percentages were rounded to one decimal place.
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Timepoint [4]
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From first dose of study drug administration until four weeks after the last dose of study drug administration, up to 16 weeks.
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Eligibility
Key inclusion criteria
- Signed and dated written informed consent in accordance with ICH Harmonized Tripartite
Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial.
- Male or female patients who are 18-50 years (inclusive) of age at time of consent.
- Established schizophrenia (as per DSM-5) with the following clinical features:
- Outpatient, with no hospitalization for worsening of schizophrenia within 3
months prior to randomization
- Psychiatrically stable without symptom exacerbation within 3 months prior to
randomization
- PANSS score = 5 on positive items P1, P3-P7 and = 4 on positive item P2 at Visit
1, and confirmed at Visit 2
- Patients must be on stable antipsychotic treatment; also, current antipsychotic
medications and concomitant anticholinergics, antiepileptics, lithium and allowed
antidepressants must meet the criteria below:
- Patients must take 1 and may take up to 2 antipsychotics (typical and/or
atypical), except for clozapine
- Patients must be stable on current antipsychotics, anticholinergics,
antiepileptics, lithium and allowed antidepressants for at least 3 months prior
to randomization and be on current dose for at least 30 days prior to
randomization o Patients on Long-Acting Injectable (LAI) antipsychotics should be
on the same medication and dose for at least 3 months prior to randomization
- Women of childbearing potential (WOCBP)2 must be ready and able to use highly
effective methods of birth control per Non-Clinical Safety Studies for the Conduct of
Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2))
that result in a low failure rate of less than 1% per year when used consistently and
correctly. A list of contraception methods meeting these criteria is provided in
Section 4.2.2.3. Such methods should be used throughout the trial, and for a period of
at least 35 days after last trial drug intake, and the patient must agree to periodic
pregnancy testing during participation in the trial.
- Patients must demonstrate their ability to properly use the CCT device and program, as
well as be compliant with CCT run-in (defined as completing at least 2 hours per week
for two weeks, totalling 4 hours CCT, during the screening period)3.
- Patients must be able to comply with all protocol procedures, in the investigator's
opinion.
- Patients must have a study partner who will preferably be consistent throughout the
study. It is recommended that the study partner should interact (in-person or
telephone) with the subject at least 2 times a week.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have a categorical diagnosis of another current major psychiatric
disorder on the Mini-International Neuropsychiatric Interview (M.I.N.I.).
- Diseases of the central nervous system (CNS) that may impact the assessment of the
cognitive tests as per investigator's opinion. A movement disorder due to
antipsychotic treatment not currently controlled with anti- EPS treatment or another
movement disorder (e.g. Parkinson´s disease).
- Patients with a history of participating in any formal cognitive remediation program
for 10 or more training sessions.
- Patients who were treated with any of the following medications within the last 6
months prior to randomization:
- Bitopertin, BI 409306, encenicline or other investigational drug testing effects
on cognition in schizophrenia
- Clozapine (atypical antipsychotic medication)
- Sarcosine, cycloserine, serine and glycine
- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
- Tricyclic antidepressants
- Patients receiving any other investigational drug (other than a potential cognitive
enhancing drug) within 30 days or 6 half-lives (whichever is longer) prior to
randomization. For investigational LAI antipsychotics, the last injection must be at
least 3 months or two administration cycles (i.e. 6 months if administration is every
3 months) prior to randomization, whichever is longer.
- Patients who have participated in a clinical trial with repeated assessments (i.e. a
single assessment is not exclusionary) with the MATRICS Consensus Cognitive Battery
(MCCB) within the last 6 months prior to randomization.
- Patients who required a change in ongoing benzodiazepine or sleep medication dose or
regimen within the last 30 days prior to randomization.
- Patients with known active infection with SARS-CoV-2 within the last 30 days prior to
randomization.
- Other exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/11/2022
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [4]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Louisiana
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Texas
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Caen
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France
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Dijon
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France
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Douai
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France
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Montpellier
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France
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Nantes
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France
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Nice
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France
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Paris
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France
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Saint Priest en Jarez
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New Zealand
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Takpuna Auckland
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United Kingdom
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Cheltenham
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study in adults with schizophrenia. The study tests whether a medicine called BI
425809 together with brain training improves mental abilities.
Participants take study medication once a day for 12 weeks. At the start of the study, the
participants are put into 2 groups. It is decided by chance who gets into which group. One
group gets BI 425809 tablets every day. The other group gets placebo tablets every day.
Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study,
all participants do brain training using a computer.
The doctors regularly test mental abilities of the participants. The results of the mental
ability tests are compared between the groups. The doctors also check the general health of
the patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03859973
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03859973
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