A study to test long-term safety of Iclepertin in people with schizophrenia BI-14 (CONNEX-X)
Summary
Trial 1346-0014 is available for subjects who have completed the Iclepertin phase III trial, which is 26 weeks of treatment with Iclepertin 10mg or matching placebo, taken once a day.
All subjects in this extension clinical trial will be offered treatment with iclepertin 10 mg taken once a day. The purpose of this 1346-0014 trial is to collect long-term safety data up to 1 year in patients with cognitive impairment due to schizophrenia taking the trial drug Iclepertin for the purpose of improving cognition and functioning.
Eligibility
Eligible gender: Male, Female
Eligible ages: 18 to 50
Inclusion criteria:
Male and female out-patients age 18-50.
Diagnosis of schizophrenia on stable antipsychotic therapy
Patients to have a consistent study partner that will support them throughout the study.
Patients, who have completed 26 weeks of treatment in the parent trial (trial #1346-0011, or 1346-0012, or1346-0013)
Exclusion criteria:
Patients who have not completed 1346-0011
Patient with 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 based on the assessment in parent trial and up to and including Visit 1 of this study.
Patients diagnosed with moderate or severe substance use disorder
Haemoglobin- Hb is below lower limit of normal in parent trial
Patients who have been diagnosed with hemoglobinopathies during the parent trial.
Participate
Additional information
Contact information
Mental Health Clinical Trials Unit University of Calgary Mathison Centre for Mental Health Research & Education CWPH Building, 1st floor 403-210-6904 natasha.wen@ucalgary.ca
Principal investigator:
Thomas Raedler
Clinical trial:
Yes
REB-ID:
REB23-0645