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Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

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ClinicalTrials.gov Identifier: NCT04846881
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: BI 425809 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : May 3, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: BI 425809 Drug: BI 425809
BI 425809

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment [ Time Frame: at baseline and at week 26 ]
    MCCB 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


Secondary Outcome Measures :
  1. Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment [ Time Frame: at baseline and at week 26 ]
    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. Higher ratings reflect a greater degree of impairment.

  2. Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [ Time Frame: at baseline and at week 26 ]
  3. Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test [ Time Frame: at baseline and at week 26 ]
  4. Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score [ Time Frame: up to 24 weeks ]
    PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Signed and dated written informed consent.
  • Male or female patients who are 18-50 years (inclusive) of age at time of consent.
  • Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).

    -- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.

  • Patients should have functional impairment in day-to-day activities per investigator judgement.
  • Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
  • Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
  • Women of childbearing potential must use highly effective methods of birth control.
  • Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Exclusion criteria

  • Patient with current DSM-5 diagnosis other than Schizophrenia.
  • Cognitive impairment due to other causes, or patients with dementia.
  • Severe movement disorders.
  • Any suicidal behavior in past year or suicidal ideation in the past 3 months.
  • History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
  • Positive urine drug screen.
  • Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
  • Current participation in any investigational drug trial.
  • Cognitive Remediation Therapy within 12 weeks prior to screening.
  • Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
  • Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
  • Haemoglobin (Hb) below lower limit of normal .
  • History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
  • Severe renal impairment.
  • Indication of liver disease.
  • Any documented active or suspected malignancy or history of malignancy within 5 years.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

Further exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846881


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Contact: Seong-Jin Cho    82 32 468 8420    sjcho@gilhospital.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jun Soo Kwon    82 2 2072 2972    kwonjs@snu.ac.kr   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04846881    
Other Study ID Numbers: 1346-0012
2020-003744-84 ( EudraCT Number )
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders