A study to test long-term safety of Iclepertin in people with schizophrenia who took part in a previous CONNEX study
Key facts
- Where
- Budapest, MagyarországSee the site
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Magyarország
- Semmelweis UniversityBudapest, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim International GmbH
- Trial code
- EU 2024-511560-93-00
- Record updated
- 2024. október 28.
- Original description
The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with Iclepertin or matching placebo of one of the phase III clinical trial program for Iclepertin (trial # 1346-0011, 1346-0012, 1346-0013).Read full original descriptionShow less
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)
The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with Iclepertin or matching placebo of one of the phase III clinical trial program for Iclepertin (trial # 1346-0011, 1346-0012, 1346-0013).
Inclusion: 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: - Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013 (i.e. Follow Up 1 timepoint including the applicable time windows). - At the end of safety follow up in 1346-0012 (within 7 days of visit Follow Up 6)."; 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; Further inclusion criteria apply.
Exclusion: Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial; 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); 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 who have been diagnosed with hemoglobinopathies during the parent trial; Further exclusion criteria apply.