Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

PHRR220921-004972

1346-0011

2022-CT0695

A phase III randomized, double-blind, 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-1)

This trial is a 26-week, multi-center, multi-national, randomized, double-blind, placebo controlled, parallel group trial in patients with schizophrenia. Patients with schizophrenia on stable antipsychotic treatment who meet the eligibility criteria are planned to be randomized in equal ratio to one of the following arms: BI 425809 10mg once daily or Placebo once daily.

Start Date Duration in Months Target Completion Date Actual Completion Date
2022-12-06 17 2024-05-06 0000-00-00

Pending

Awaiting complete EC approvals (required for site initiation/activation)

Institution Classification Region LTO #
Boehringer Ingelheim (Philippines), Inc. Private Business NCR CDRR-NCR-S-267577
Institution Region
Boehringer Ingelheim Korea Ltd South Korea
Name E-Mail Institution and Institution Address
Dr. Greta Cortez MEDROPUSEASKRegistry.SG@boehringer-ingelheim.com Boehringer Ingelheim (Philippines) Inc., 23rd Floor BDO Towers Valero Bldg., 8741 Paseo de Roxas, Bel-Air, Makati City, 1227 Philippines
Name E-Mail Institution and Institution Address
Dr. Greta Cortez MEDROPUSEASKRegistry.SG@boehringer-ingelheim.com Boehringer Ingelheim (Philippines) Inc., 23rd Floor BDO Towers Valero Bldg., 8741 Paseo de Roxas, Bel-Air, Makati City, 1227 Philippines
Name Expertise Affiliation
Evelyn Gapuz, MD Psychiatry Philippine General Hospital
Fe Costales, MD Psychiatry Cebu North General Hospital
Luzviminda Katigbak, MD Psychiatry Makati Medical Center
Rowena Cosca, MD Psychiatry St. Paul's Hospital, Iloilo
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Philippine General Hospital Ward 7, Room 108, Philippine General Hospital, Taft Avenue, Ermita Manila, Philippines University of the Philippines Manila - Research Ethics Board Evelyn Gapuz, MD Psychiatry
Cebu North General Hospital Cebu North General Hospital, Kauswagan Road, Talamban, Cebu City, Cebu Cebu Doctors' University Hospital - Research Ethics Committee Fe Costales, MD Psychiatry
Makati Medical Center Makati Medical Center, 2 Amorsolo Street, Legaspi Village, Makati City, Philippines Makati Medical Center Institutional Review Board Luzviminda Katigbak, MD Psychiatry
St. Paul's Hospital, Iloilo Rm. 309, Pere Louis Chauvet Complex, St. Paul's Hospital, Iloilo City 5000 Philippines St. Paul’s Hospital Iloilo – Institutional Ethics Review Board Rowena Cosca, MD Psychiatry
Project Location Institutional Ethics Review Board
Philippine General Hospital University of the Philippines Manila - Research Ethics Board
Cebu North General Hospital Cebu Doctors' University Hospital - Research Ethics Committee
Makati Medical Center Makati Medical Center Institutional Review Board
St. Paul's Hospital, Iloilo St. Paul’s Hospital Iloilo – Institutional Ethics Review Board

Clinical Trial

Unspecified

Schizophrenia

Primary Objective: To assess the efficacy in improving cognitive impairment using Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in patients with schizophrenia treated for 26 weeks with BI 425809 10mg as compared to placebo.

Primary Endpoint: 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. 

Key Secondary Objective: To assess the efficacy in daily functioning using Schizophrenia Cognition Rating Scale (SCoRS) and Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in patients with schizophrenia treated for 26-week treatment with BI 425809 10mg as compared to placebo.

Key Secondary Efficacy endpoints include:

  • Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment.
  • Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Pending

  • Australia
  • Brazil
  • Canada
  • China
  • Colombia
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Russia
  • Sweden
  • Turkey
  • United States

1346-0011

20220714105057

2022-09-01

0000-00-00

Protocol Code Number 1346-0011
Protocol Version Unspecified
Date of Protocol Version Unspecified

20

Unspecified

Unspecified

Unspecified

0000-00-00

Main Inclusion:

  • 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, fifth edition (DSM-5) with the following clinical features:
    • Outpatient, clinically stable and in the residual (non-acute) phase of their illness.
    • No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization.
    • PANSS score: items P1, P3-P6 ≤5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2
  • Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties staying focused, difficulties remembering instructions, what to say or how to get to places, per investigator judgement.
  • Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) 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.
  • Have a study partner, defined as any person who knows the patient well, who has been capable of interacting with the patient on a regular basis, preferably consistent throughout the study, either private or professional.

Main Exclusion:

  • Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar schizoaffective, major depressive disorder, etc. M.I.N.I for psychotic disorders should be used for guidance.
  • Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia
  • Any suicidal behavior in the past 1 -year prior to screening and during the screening period.
  • Suicidal ideation of type 5 in the C-SSRS in the past 3 months prior to screening and up to and including Visit 2.
  • Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including Visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.
  • Haemoglobin (Hb) below lower limit of normal at Visit 1 assessed by the central lab

Interventional

BI 425809

BI 425809 film-coated tablets 10 mg are pinkish white, oval (about 9.5 x 4.6 mm), and biconvex. One side is debossed with the BI company symbol, and the other side is debossed with 'J10'.

None

Method of Allocation

Randomized

Masking or Blinding

Double Blind

Masking Details

Unspecified

Control

Unspecified

Assignment

Parallel

Phase

Phase III

Purpose of the Study

To assess the efficacy in improving cognitive impairment using Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in patients with schizophrenia treated for 26 weeks with BI 425809 10mg as compared to placebo.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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