schizophrenia with persistent prominent negative symptoms MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Code: Lu AF11167 modified-release tablet
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: LU AF11167
Current Sponsor code: LU AF11167 hemiadipate
Other descriptive name: LU
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient completed Study 17972A. • The patient and the patient’s caregiver or identified responsible person is able to read and understand the Informed Consent Form. • The patient has signed the Informed Consent Form specific for Study 17972B. • The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator’s clinical judgment. Other inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A • The patient, in the opinion of the investigator, is at significant risk of suicide Other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A study to evaluate the long-term safety and tolerability of flexible doses of LuAF11167 in patients with schizophrenia during the 24-week treatment;Secondary Objective: N/A;Primary end point(s): 1.Number of participants with Treatment-Emergent Adverse Events;Timepoint(s) of evaluation of this end point: 1.[Time Frame: From baseline week 24] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Change in Brief Negative Symptom Scale (BNSS) total score 3. Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score 4. Change in PANSS Negative subscale score 5. Change in CGI-SCH-S negative symptoms score 6. CGI-SCH-DC negative symptoms score 7. CGI-SCH-DC negative symptoms response;Timepoint(s) of evaluation of this end point: 2.[Time Frame: from baseline to Week 24] 3.[Time Frame: from baseline to Week 24] 4.[Time Frame: from baseline to Week 24] 5.[Time Frame: from baseline to Week 24] 6.[Time Frame: at Week 24] 7.[Time Frame: at Week 24] | — |
Countries
Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Poland, Russian Federation, Ukraine
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed