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History of Changes for Study: NCT03859973
This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
Latest version (submitted September 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 28, 2019 None (earliest Version on record)
2 March 4, 2019 Study Status
3 March 18, 2019 Study Status
4 April 17, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 April 29, 2019 Contacts/Locations and Study Status
6 May 13, 2019 Study Status and Contacts/Locations
7 May 28, 2019 Contacts/Locations and Study Status
8 June 10, 2019 Study Status and Contacts/Locations
9 June 24, 2019 Contacts/Locations and Study Status
10 July 8, 2019 Study Status and Contacts/Locations
11 July 24, 2019 Contacts/Locations and Study Status
12 August 5, 2019 Study Status and Contacts/Locations
13 August 21, 2019 Contacts/Locations and Study Status
14 September 2, 2019 Study Status
15 September 16, 2019 Contacts/Locations and Study Status
16 October 1, 2019 Contacts/Locations and Study Status
17 October 15, 2019 Study Status
18 October 29, 2019 Contacts/Locations and Study Status
19 November 1, 2019 Study Status and Eligibility
20 November 13, 2019 Contacts/Locations and Study Status
21 November 25, 2019 Contacts/Locations and Study Status
22 December 10, 2019 Contacts/Locations and Study Status
23 December 20, 2019 Contacts/Locations and Study Status
24 January 7, 2020 Study Status
25 January 20, 2020 Contacts/Locations and Study Status
26 February 3, 2020 Contacts/Locations and Study Status
27 February 17, 2020 Contacts/Locations and Study Status
28 March 2, 2020 Study Status
29 March 17, 2020 Study Status
30 April 3, 2020 Recruitment Status, Study Status and Contacts/Locations
31 April 21, 2020 Contacts/Locations and Study Status
32 May 6, 2020 Study Status
33 May 19, 2020 Study Status
34 May 22, 2020 Recruitment Status, Study Status and Contacts/Locations
35 June 3, 2020 Contacts/Locations and Study Status
36 June 15, 2020 Contacts/Locations and Study Status
37 June 29, 2020 Contacts/Locations and Study Status
38 July 13, 2020 Contacts/Locations and Study Status
39 July 27, 2020 Contacts/Locations and Study Status
40 August 11, 2020 Study Status and Contacts/Locations
41 August 17, 2020 Eligibility and Study Status
42 September 10, 2020 Contacts/Locations and Study Status
43 September 22, 2020 Contacts/Locations and Study Status
44 October 4, 2020 Contacts/Locations and Study Status
45 October 20, 2020 Contacts/Locations, Study Status and References
46 November 4, 2020 Study Status and Contacts/Locations
47 November 17, 2020 Contacts/Locations and Study Status
48 December 1, 2020 Contacts/Locations and Study Status
49 December 15, 2020 Study Status
50 January 11, 2021 Study Status
51 February 1, 2021 Study Description and Study Status
52 February 8, 2021 Study Status
53 February 22, 2021 Contacts/Locations and Study Status
54 March 10, 2021 Study Status and Contacts/Locations
55 March 22, 2021 Contacts/Locations and Study Status
56 April 8, 2021 Contacts/Locations and Study Status
57 April 20, 2021 Contacts/Locations and Study Status
58 May 4, 2021 Study Status
59 May 17, 2021 Contacts/Locations, IPDSharing and Study Status
60 June 4, 2021 IPDSharing and Study Status
61 June 28, 2021 Contacts/Locations and Study Status
62 July 12, 2021 Study Status
63 August 10, 2021 Study Status and Contacts/Locations
64 September 6, 2021 Contacts/Locations and Study Status
65 September 24, 2021 Contacts/Locations and Study Status
66 October 4, 2021 Contacts/Locations and Study Status
67 October 19, 2021 Study Status and Contacts/Locations
68 November 2, 2021 Study Status and Contacts/Locations
69 November 17, 2021 Contacts/Locations and Study Status
70 December 1, 2021 Contacts/Locations and Study Status
71 December 13, 2021 Study Status
72 January 10, 2022 Contacts/Locations and Study Status
73 February 9, 2022 Study Status
74 February 21, 2022 Contacts/Locations and Study Status
75 March 10, 2022 Study Status and Contacts/Locations
76 April 4, 2022 Study Status
77 April 19, 2022 Contacts/Locations and Study Status
78 May 2, 2022 Study Status and Contacts/Locations
79 May 17, 2022 Contacts/Locations and Study Status
80 June 17, 2022 Contacts/Locations and Study Status
81 June 28, 2022 Recruitment Status, Contacts/Locations and Study Status
82 July 11, 2022 Study Status
83 July 19, 2022 Contacts/Locations, Study Design and Study Status
84 July 27, 2022 Study Status
85 August 9, 2022 Study Status
86 September 1, 2022 Study Status
87 September 6, 2022 Study Status
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Study NCT03859973
Submitted Date:  February 28, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1346-0038
Brief Title: This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
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
Secondary IDs: 2018-002740-82 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Not yet recruiting
Study Start: March 19, 2019
Primary Completion: November 27, 2020 [Anticipated]
Study Completion: December 25, 2020 [Anticipated]
First Submitted: February 25, 2019
First Submitted that
Met QC Criteria:
February 28, 2019
First Posted: March 1, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
February 28, 2019
Last Update Posted: March 1, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).
Detailed Description:
Open or close this module Conditions
Conditions: Schizophrenia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BI 425809
Active drug treatment arm
Drug: BI 425809
Tablet
Experimental: Placebo
Placebo drug arm
Drug: Placebo
Tablet
Open or close this module 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)
[ Time Frame: 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)
[ Time Frame: 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
[ Time Frame: Up to 12 weeks ]

Schizophrenia Cognition Rating Scale (SCoRS)
3. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
[ Time Frame: Up to 12 weeks ]

Positive and Negative Syndrome Scale (PANSS)
4. Percentage of patients with (S)AEs
[ Time Frame: Up to 12 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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, and current antipsychotic and concomitant psychotropic medications must meet the criteria below:
    • Patients may take up to 2 antipsychotics (typical and/or atypical), except for clozapine
    • Patients must be stable on current antipsychotics and concomitant psychotropic medications (e.g. 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 ---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. 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 computerized cognitive training (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).
  • Patients must be able to comply with all protocol procedures including the at-home CCT exercises, 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.
  • Use of systemic steroids within 30 days prior to randomization.
  • Patients taking strong or moderate CYP3A4 inhibitors or inducers within the last 30 days prior to randomization. A list of strong or moderate CYP3A4 inhibitors and inducers will be provided in the ISF.
  • Patients who must or wish to continue the intake of restricted medications or herbal remedies
  • Patients who received treatment with medical devices (e.g. TMS, neurofeedback) for any psychiatric condition within the last 3 months prior to randomization.
  • Patients who have received electroconvulsive therapy (ECT) within 6 months prior to randomization or repeated courses of ECT within the past 2 years.
  • Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to randomization.
  • Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) prior to randomization.
  • Any of the following, in the judgment of the investigator:
    • Clinically significant finding of the physical examination, vital signs (including blood pressure (BP) and pulse rate (PR)), ECG or laboratory value (as measured by the central laboratory) that would jeopardize the patient's safety while participating in the trial or their capability to participate in the trial.
    • Symptomatic/unstable/uncontrolled or clinically relevant concomitant disease or any other clinical condition that would jeopardize the patient's safety while participating in the trial or capability to participate in the trial.
    • Significant or unstable physical condition that may require change in medication or hospitalization that would impact cognitive function, or planned elective surgery requiring general anesthesia during the study period.
    • Patients for which cognitive or other impairment (including severe hearing impairment) or symptom severity compromises the ability to perform the CCT or assessments related to cognitive outcome measures.
  • Severe renal impairment defined as an eGFR < 30mL/min/1.73m² in the Visit 1 central lab report.
  • Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 times upper limit of normal as determined in the Visit 1 central lab report.
  • Known history of HIV infection and/or a positive result for ongoing Hepatitis B or C infection on the Visit 1 central lab report.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Hb less than 120 g/L (12g/dL) in men or 115 g/L (11.5g/dL) in women at Visit 1.
  • History of hemoglobinopathy such as thalassemia major or sickle-cell anemia.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Significant history of drug abuse disorder within the last 6 months prior to informed consent (including alcohol, as defined in DSM-5-substance use disorder or in the opinion of the investigator), or a positive urine drug screen at Visit 1. Note: Patients testing positive for cannabis on urine drug screen at Visit 1 may be re-tested once, at least 2 weeks after the first urine drug screen, if there is a reasonable explanation and expectation that the patient will not test positive again on re-test, and at the discretion of the investigator.
  • Patients who are not fluent in the language of the batteries/questionnaires which will be used in the country.
  • Patient who did not make an effortful attempt to complete the cognition battery at Visit 1 in the clinical judgement of the investigator.
  • Patients that previously received treatment in any study with BI 425809.
  • Patients with an allergy to BI 425809 and/or any of the excipients (including lactose) or placebo ingredients. A list of BI 425809 and placebo ingredients will be provided in the ISF.
Open or close this module Contacts/Locations
Central Contact Person: Boehringer Ingelheim
Telephone: 1-800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services