Schizophrenia
Conditions
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.
Interventions
DRUGIclepertin
One 10 milligram (mg) tablet once daily.
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
No
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Treatment Emergent Adverse Events (TEAEs) | From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks. | Number of participants with treatment emergent adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT) | At baseline and at EOT. Up to a maximum of 60.1 weeks. | The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \[CGI-S EOT\] - \[CGI-S baseline\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe. |
| Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT) | At baseline and at EOT. Up to a maximum of 60.1 weeks. | Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Multi-center, multi-national, open label, single arm extension trial in patients with cognitive impairment due to schizophrenia who had completed 26 weeks of treatment with 10 milligrams (mg) iclepertin or matching placebo, taken once daily in one of the three Phase III (CONNEX) parent trials (trial 1346-0011, 1346-0012 or 1346-0013).
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 425 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 912 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 103 Participants |
| Race (NIH/OMB) Asian | 418 Participants |
| Race (NIH/OMB) Black or African American | 112 Participants |
| Race (NIH/OMB) More than one race | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 682 Participants |
| Sex: Female, Male Female | 477 Participants |
| Sex: Female, Male Male | 879 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 1,356 |
| other Total, other adverse events | 261 / 1,356 |
| serious Total, serious adverse events | 82 / 1,356 |
Outcome results
None listed