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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05211947
Registration number
NCT05211947
Ethics application status
Date submitted
14/01/2022
Date registered
27/01/2022
Titles & IDs
Public title
A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
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Scientific title
An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)
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Secondary ID [1]
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0
2020-003745-11
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Secondary ID [2]
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0
1346-0014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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0
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Condition category
Condition code
Mental Health
0
0
0
0
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Iclepertin
Experimental: Patients with cognitive impairment due to schizophrenia -
Treatment: Drugs: Iclepertin
Iclepertin
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Occurrence of treatment emergent adverse events (TEAEs)
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Assessment method [1]
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0
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Timepoint [1]
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up to 1 year and 12 days
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Secondary outcome [1]
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Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT)
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Assessment method [1]
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The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S is rated ordinal from 1 to 7, with 1=normal (not at all ill) to 7=patient among the most extremely ill patients.
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Timepoint [1]
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up to 1 year
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Secondary outcome [2]
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Change from baseline in Haemoglobin (Hb) to EOT
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Assessment method [2]
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0
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Timepoint [2]
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up to 1 year
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Signed and dated written informed consent.
* 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 participation in the parent trial.
* 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.
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Minimum age
18
Years
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Maximum age
51
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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 since enrolment into the parent phase III trial.
* Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.
* Positive urine drug screen = 3 times during the treatment period of parent trial.
* Patients who are currently or wish to participate in another investigational drug trial.
* Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/12/2025
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Actual
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Sample size
Target
1401
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
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Busan
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Daegu
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Gyeonggi-Do
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Incheon
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Seoul
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Yangsan
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Lithuania
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Kaunas
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Silute
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Ciudad de Mexico
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Takpuna Auckland
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Moss
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Oslo
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Bialystok
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Zabrze
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Romania
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Bucharest
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Sibiu
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Belgrade
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Serbia
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Gornja Toponica
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Serbia
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Novi Knezevac
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Serbia
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Novi Sad
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Bojnice
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Helsingborg
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Uppsala
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Kaohsiung
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Keelung
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Taichung
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Tainan
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Taoyuan
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Bodmin
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United Kingdom
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Chester
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term. Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia. Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team. The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
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Trial website
https://clinicaltrials.gov/study/NCT05211947
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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Address
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Phone
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1-800-243-0127
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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".
Furthermore, researchers can 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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
After structured results have been posted, 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.
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Available to whom?
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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05211947