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This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03859973
Collaborator
(none)
200
Enrollment
51
Locations
2
Arms
42.7
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 425809
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Apr 15, 2019
Anticipated Primary Completion Date :
Oct 7, 2022
Anticipated Study Completion Date :
Nov 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 425809

Active drug treatment arm

Drug: BI 425809
Tablet
Experimental: Placebo

Placebo drug arm

Drug: Placebo
Tablet

Outcome Measures

Primary Outcome Measures

  1. 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) [Up to 12 weeks]

Secondary Outcome Measures

  1. Change from baseline in cognitive function as measured by the overall MCCB composite score (including social cognition) [Up to 12 weeks]

  2. Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score [Up to 12 weeks]

    Schizophrenia Cognition Rating Scale (SCoRS)

  3. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [Up to 12 weeks]

    Positive and Negative Syndrome Scale (PANSS)

  4. Percentage of patients with (S)AEs [Up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atria Clinical Research Little Rock Arkansas United States 72209
2 Woodland Research Northwest Rogers Arkansas United States 72758
3 Encino Hospital Medical Center Encino California United States 91436
4 Collaborative Neuroscience Network, LLC (CNS) Garden Grove California United States 92845
5 Synergy San Diego Lemon Grove California United States 91945
6 Catalina Research Institute, LLC Montclair California United States 91763
7 Pacific Research Partners, LLC Oakland California United States 94607
8 NRC Research Institute Orange California United States 92868
9 CNRI - Los Angeles Pico Rivera California United States 90660
10 CNRI-San Diego, LLC San Diego California United States 92102
11 Collaborative Neuroscience Network, LLC (CNS) Torrance California United States 90502
12 Meridien Research Maitland Florida United States 32751
13 Premier Clinical Research Institute Miami Florida United States 33122
14 University of Miami Miami Florida United States 33136
15 Apalachee Center Tallahassee Florida United States 32308
16 Jerome Golden Center for Behavioral Health West Palm Beach Florida United States 33407
17 Synexus Atlanta Georgia United States 30328
18 Uptown Research Institute Chicago Illinois United States 60640
19 Lake Charles Clinical Trials LLC Lake Charles Louisiana United States 70629
20 Cherry Health Grand Rapids Michigan United States 49503
21 Center for Behavioral Medicine Kansas City Missouri United States 64108
22 Synexus Clinical Research US, Inc. New York New York United States 10017
23 UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center Raleigh North Carolina United States 27608
24 Midwest Clinical Research Dayton Ohio United States 45417
25 FutureSearch Trials of Dallas, LP Dallas Texas United States 75231
26 Pillar Clinical Research, LLC Richardson Texas United States 75080
27 Office of Dr. Aqeel Hashmi, MD, PA Richmond Texas United States 77407
28 Northwest Clinical Research Center Bellevue Washington United States 98007
29 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
30 Monash Medical Centre Clayton Victoria Australia 3168
31 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
32 Monash Alfred Psychiatry Research Centre Melbourne Victoria Australia 3004
33 University of Calgary Calgary Alberta Canada T2N 4Z6
34 BC Mental Health and Addictions Research Institute (University of British Columbia) Vancouver British Columbia Canada V5Z 4H4
35 Centre for Addiction and Mental Health (CAMH) Toronto Ontario Canada M6J 1H4
36 IUSMM Institut Universitaire en Sante Mentale de Montreal Montreal Quebec Canada H1N 3M5
37 CTR Esquirol Caen France 14033
38 HOP Dijon-Bourgogne Dijon France 21079
39 CAB Médical Psyché Douai France 59500
40 HOP la Colombière Montpellier France 34295
41 HOP Saint-Jacques Nantes France 44093
42 HOP Pasteur Nice France 06000
43 GHU Paris Psychiatrie et Neurosciences Paris France 75674
44 HOP Nord Saint Priest en Jarez France 42270
45 North Shore Hospital, Takapuna Takpuna Auckland New Zealand 0622
46 Holywell Hospital Antrim United Kingdom BT41 2RJ
47 The Fritchie Centre Cheltenham United Kingdom GL53 9DZ
48 Royal Edinburgh Hospital Edinburgh United Kingdom EH10 5HF
49 Queen Elizabeth University Hospital Glasgow United Kingdom G51 4TF
50 Maudsley Hospital London United Kingdom SE5 8AZ
51 Warneford Hospital Oxford United Kingdom OX3 7JX

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03859973
Other Study ID Numbers:
  • 1346-0038
  • 2018-002740-82
First Posted:
Mar 1, 2019
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia
BI 425809

Study Results

No Results Posted as of Aug 10, 2022