Clinical Trials List
2021-10-01 - 2025-04-18
Phase III
Not yet recruiting9
Recruiting1
An open label, single arm, extension trial to examine long-term safety of BI 425809 once daily in patients with schizophrenia who have completed previous BI 425809 Phase III trials (CONNEX-X)
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林式穀 Division of Psychiatry
- Mao-Hsiu Hua Division of Psychiatry
- 周亞欣 Division of Psychiatry
- 沈信衡 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 許文郁 Division of Psychiatry
- 陳昱安 Division of Psychiatry
- 陳力源 Division of Psychiatry
- YI-CHUN LIU Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 黃郁絜 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 劉震鐘 無
- YI-LING CHIEN Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
- YI-TING LIN Division of Psychiatry
- Tzung-Jeng Hwang Division of Psychiatry
- 劉耀臨 Division of Ophthalmology
- 謝明憲 Division of Psychiatry
Audit
None
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
adverse events (TEAEs) throughout the extension study.
Note: TEAEs are defined as all adverse events (AE) occurring between start of treatment in the extension trial and the end of its
residual effect period (REP). AE that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial will also be considered as ‘treatment-emergent’
The secondary endpoints are change from baseline in Clinical Global Impressions-Severity (CGI-S) to end of treatment (EOT) and
Change from baseline in Hb to EOT.
Inclution Criteria
• Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)).
• Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial:
o Within 2 weeks the end of treatment visit in 1346-0011,1346-0013.
o At the end of safety follow up in 1346-0012.
• Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on a regular basis.
Preferably be the same person throughout the study.
Exclusion Criteria
• Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient
from participating in the extension trial
• Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of
this study.
• Patients diagnosed with moderate or severe substance use disorder
• Haemoglobin- Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial)
• Patients who have been diagnosed with hemoglobinopathies during the parent trial.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
1400 participants
