Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
- Registration Number
- NCT02892422
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
- 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.
- 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 exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Flexible-dose of Lu AF35700 Lu AF35700 -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (102)
US1244
🇺🇸Fresh Meadows, New York, United States
US1404
🇺🇸Shreveport, Louisiana, United States
US1190
🇺🇸Staten Island, New York, United States
US1130
🇺🇸Miami, Florida, United States
US1444
🇺🇸Las Vegas, Nevada, United States
US1402
🇺🇸Oakland Park, Florida, United States
CZ1032
🇨🇿Brno, Czechia
CZ1013
🇨🇿Lnáře, Czechia
CZ1038
🇨🇿Praha, Czechia
RS1011
🇷🇸Kragujevac, Serbia
RS1009
🇷🇸Novi Kneževac, Serbia
US1463
🇺🇸Culver City, California, United States
US1399
🇺🇸Escondido, California, United States
US1104
🇺🇸Garden Grove, California, United States
US1391
🇺🇸San Bernardino, California, United States
US1392
🇺🇸Torrance, California, United States
US1368
🇺🇸Orange, California, United States
BG1030
🇧🇬Burgas, Bulgaria
SK1014
🇸🇰Bratislava, Slovakia
US1018
🇺🇸Bellflower, California, United States
US1459
🇺🇸Oceanside, California, United States
US1114
🇺🇸National City, California, United States
US1318
🇺🇸Lauderhill, Florida, United States
US1129
🇺🇸North Miami, Florida, United States
US1403
🇺🇸Atlanta, Georgia, United States
US1009
🇺🇸Atlanta, Georgia, United States
US1398
🇺🇸Shreveport, Louisiana, United States
US1423
🇺🇸Hoffman Estates, Illinois, United States
US1046
🇺🇸Chicago, Illinois, United States
US1086
🇺🇸Flowood, Mississippi, United States
US1426
🇺🇸Berlin, New Jersey, United States
US1394
🇺🇸New York, New York, United States
US1416
🇺🇸New York, New York, United States
US1171
🇺🇸Rochester, New York, United States
US1390
🇺🇸Charlotte, North Carolina, United States
US1124
🇺🇸Norristown, Pennsylvania, United States
US1065
🇺🇸Dallas, Texas, United States
BG1028
🇧🇬Kazanlak, Bulgaria
US1451
🇺🇸Austin, Texas, United States
BG1003
🇧🇬Lovech, Bulgaria
BG1008
🇧🇬Plovdiv, Bulgaria
BG1024
🇧🇬Sofia, Bulgaria
BG1026
🇧🇬Sofia, Bulgaria
BG1034
🇧🇬Varna, Bulgaria
BG1029
🇧🇬Veliko Tŭrnovo, Bulgaria
BG1027
🇧🇬Vratsa, Bulgaria
CA1029
🇨🇦Penticton, Canada
CZ1023
🇨🇿Brno, Czechia
EE1007
🇪🇪Tallinn, Estonia
MX1024
🇲🇽Durango, Mexico
MX1011
🇲🇽Guadalajara, Mexico
MX1021
🇲🇽Guadalajara, Mexico
MX1020
🇲🇽Mexico City, Mexico
MX1022
🇲🇽Guadalajara, Mexico
MX1007
🇲🇽Monterrey, Mexico
MX1015
🇲🇽Monterrey, Mexico
PL1043
🇵🇱Bialystok, Poland
PL1058
🇵🇱Pruszcz Gdanski, Poland
PL1059
🇵🇱Toruń, Poland
PL1060
🇵🇱Łódź, Poland
RU1009
🇷🇺Arkhangel'sk, Russian Federation
RU1021
🇷🇺Gatchina, Russian Federation
RU1051
🇷🇺Moscow, Russian Federation
RU1053
🇷🇺Roshchino, Russian Federation
RU1023
🇷🇺Saint Petersburg, Russian Federation
RU1031
🇷🇺Saint Petersburg, Russian Federation
RU1030
🇷🇺Saint Petersburg, Russian Federation
RU1050
🇷🇺Yaroslavl, Russian Federation
RU1049
🇷🇺Saint Petersburg, Russian Federation
RU1052
🇷🇺Saint Petersburg, Russian Federation
RU1056
🇷🇺Saint Petersburg, Russian Federation
RS1008
🇷🇸Belgrade, Serbia
RS1010
🇷🇸Belgrade, Serbia
RS1001
🇷🇸Kovin, Serbia
RS1012
🇷🇸Belgrad, Serbia
RS1016
🇷🇸Kragujevac, Serbia
RS1017
🇷🇸Kragujevac, Serbia
SK1024
🇸🇰Bratislava, Slovakia
SK1026
🇸🇰Zlaté Moravce, Slovakia
ES1047
🇪🇸Barcelona, Spain
ES1008
🇪🇸Málaga, Spain
UA1017
🇺🇦Kharkiv, Ukraine
ES1048
🇪🇸Oviedo, Spain
UA1035
🇺🇦Kharkiv, Ukraine
UA1027
🇺🇦Kiev, Ukraine
UA1028
🇺🇦Kiev, Ukraine
UA1030
🇺🇦Kiev, Ukraine
UA1031
🇺🇦Kiev, Ukraine
UA1033
🇺🇦Lviv, Ukraine
UA1020
🇺🇦Odesa, Ukraine
UA1019
🇺🇦Odessa, Ukraine
UA1032
🇺🇦Oleksandrivka, Ukraine
UA1036
🇺🇦Vinnitsa, Ukraine
US1062
🇺🇸Costa Mesa, California, United States
MX1005
🇲🇽Monterrey, Mexico
UA1001
🇺🇦Poltava, Ukraine
RU1055
🇷🇺Moscow, Russian Federation
RU1006
🇷🇺Moscow, Russian Federation
RO1024
🇷🇴Bucharest, Romania
PL1051
🇵🇱Wrocław, Poland
RU1028
🇷🇺Saint Petersburg, Russian Federation
UA1029
🇺🇦Kherson, Ukraine