Schizophrenia
Conditions
Brief summary
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
Detailed description
Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.
Interventions
DRUGLu AF35700
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- For 16159A-patients * The patient has completed Study 16159A. * The patient is able to read and understand the Informed Consent Form. * The patient has signed the Informed Consent Form specific for Study 16159B. * The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement. For 16323A-patients * The patient has completed the dosing period of Study 16323A. * The patient is able to read and understand the Informed Consent Form. * The patient has signed the Informed Consent Form specific Study 16159B. * The patient has a confirmed diagnosis of schizophrenia according to DSM-5™. * The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement. For Other Patients * The patient has schizophrenia, diagnosed according to DSM-5™. * The patient is a man or woman, aged ≥18 years. * The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit. * The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits. * The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4. * The patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons: * lack of adequate response to his or her current antipsychotic medication; * poor tolerability to his or her current antipsychotic medication; * unwillingness of the patient to adhere to his or her current antipsychotic medication.
Exclusion criteria
\- For 16159A-patients * The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A. * The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers Yes to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers Yes to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS For 16323A-patients * The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A. * The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers Yes to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers Yes to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS For Other Patients * The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis. * The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit. * The patient is treated with clozapine at the time of the Screening Visit. * The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication. * The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers Yes to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers Yes to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | From dosing to end of study (57 weeks) | Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG) |
Countries
Bulgaria, Canada, Czechia, Estonia, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine, United States
Participant flow
Pre-assignment details
Participants who had completed either study 16159A or 16323A were enrolled. Participants from study 16323A were excluded from the all patients treated dataset and from the full analysis dataset.
Participants by arm
| Arm | Count |
|---|---|
| Flexible-dose of Lu AF35700 Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study | 528 |
| Total | 528 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 38 |
| Overall Study | Enrolled not treated | 4 |
| Overall Study | exclusion criteria met | 3 |
| Overall Study | Investigator decision | 1 |
| Overall Study | Lack of Efficacy | 32 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | moving elsewhere | 4 |
| Overall Study | non-compliance | 10 |
| Overall Study | Non-compliance with study drug | 11 |
| Overall Study | patient decision | 7 |
| Overall Study | patient legally incapable | 1 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | sponsor information 16159A results | 21 |
| Overall Study | Withdrawal by Subject | 56 |
| Overall Study | withdrawal of consent | 13 |
Baseline characteristics
| Characteristic | Flexible-dose of Lu AF35700 |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 51 Participants |
| Race (NIH/OMB) White | 412 Participants |
| Region of Enrollment Bulgaria | 107 participants |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment Czechia | 11 participants |
| Region of Enrollment Estonia | 16 participants |
| Region of Enrollment Mexico | 57 participants |
| Region of Enrollment Poland | 19 participants |
| Region of Enrollment Romania | 3 participants |
| Region of Enrollment Russia | 112 participants |
| Region of Enrollment Serbia | 43 participants |
| Region of Enrollment Slovakia | 8 participants |
| Region of Enrollment Spain | 3 participants |
| Region of Enrollment Ukraine | 48 participants |
| Region of Enrollment United States | 98 participants |
| Sex: Female, Male Female | 220 Participants |
| Sex: Female, Male Male | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 524 |
| other Total, other adverse events | 43 / 524 |
| serious Total, serious adverse events | 28 / 524 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
Time frame: From dosing to end of study (57 weeks)
Population: Participants from study 16323A were excluded from the all patients treated dataset and from the full analysis dataset.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flexible-dose of Lu AF35700 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | 289 Participants |