Clinical trial NCT02892422: Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
Official title: Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: From dosing to end of study (57 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: US1018
state: California
city: Costa Mesa
country: United States
facility: US1062
state: California
city: Culver City
country: United States
facility: US1463
state: California
city: Escondido
country: United States
facility: US1399
state: California
city: Garden Grove
country: United States
facility: US1104
state: California
city: National City
country: United States
facility: US1114
state: California
city: Oceanside
country: United States
facility: US1459
state: California
city: Orange
country: United States
facility: US1368
state: California
city: San Bernardino
country: United States
facility: US1391
state: California
city: Torrance
country: United States
facility: US1392
state: California
city: Lauderhill
country: United States
facility: US1318
state: Florida
city: Miami
country: United States
facility: US1130
state: Florida
city: North Miami
country: United States
facility: US1129
state: Florida
city: Oakland Park
country: United States
facility: US1402
state: Florida
city: Atlanta
country: United States
facility: US1403
state: Georgia
city: Atlanta
country: United States
facility: US1009
state: Georgia
city: Chicago
country: United States
facility: US1046
state: Illinois
city: Hoffman Estates
country: United States
facility: US1423
state: Illinois
city: Shreveport
country: United States
facility: US1398
state: Louisiana
city: Shreveport
country: United States
facility: US1404
state: Louisiana
city: Flowood
country: United States
facility: US1086
state: Mississippi
city: Las Vegas
country: United States
facility: US1444
state: Nevada
city: Berlin
country: United States
facility: US1426
state: New Jersey
city: Fresh Meadows
country: United States
facility: US1244
state: New York
city: New York
country: United States
facility: US1394
state: New York
city: New York
country: United States
facility: US1416
state: New York
city: Rochester
country: United States
facility: US1171
state: New York
city: Staten Island
country: United States
facility: US1190
state: New York
city: Charlotte
country: United States
facility: US1390
state: North Carolina
city: Norristown
country: United States
facility: US1124
state: Pennsylvania
city: Austin
country: United States
facility: US1451
state: Texas
city: Dallas
country: United States
facility: US1065
state: Texas
city: Burgas
country: Bulgaria
facility: BG1030
city: Kazanlak
country: Bulgaria
facility: BG1028
city: Lovech
country: Bulgaria
facility: BG1003
city: Plovdiv
country: Bulgaria
facility: BG1008
city: Sofia
country: Bulgaria
facility: BG1024
city: Sofia
country: Bulgaria
facility: BG1026
city: Varna
country: Bulgaria
facility: BG1034
city: Veliko Tŭrnovo
country: Bulgaria
facility: BG1029
city: Vratsa
country: Bulgaria
facility: BG1027
city: Penticton
country: Canada
facility: CA1029
city: Brno
country: Czechia
facility: CZ1023
city: Brno
country: Czechia
facility: CZ1032
city: Lnáře
country: Czechia
facility: CZ1013
city: Praha
country: Czechia
facility: CZ1038
city: Tallinn
country: Estonia
facility: EE1007
city: Durango
country: Mexico
facility: MX1024
city: Guadalajara
country: Mexico
facility: MX1011
city: Guadalajara
country: Mexico
facility: MX1021
city: Guadalajara
country: Mexico
facility: MX1022
city: Mexico City
country: Mexico
facility: MX1020
city: Monterrey
country: Mexico
facility: MX1005
city: Monterrey
country: Mexico
facility: MX1007
city: Monterrey
country: Mexico
facility: MX1015
city: Bialystok
country: Poland
facility: PL1043
city: Pruszcz Gdanski
country: Poland
facility: PL1058
city: Toruń
country: Poland
facility: PL1059
city: Wrocław
country: Poland
facility: PL1051
city: Łódź
country: Poland
facility: PL1060
city: Bucharest
country: Romania
facility: RO1024
city: Arkhangel'sk
country: Russian Federation
facility: RU1009
city: Gatchina
country: Russian Federation
facility: RU1021
city: Moscow
country: Russian Federation
facility: RU1006
city: Moscow
country: Russian Federation
facility: RU1051
city: Moscow
country: Russian Federation
facility: RU1055
city: Roshchino
country: Russian Federation
facility: RU1053
city: Saint Petersburg
country: Russian Federation
facility: RU1023
city: Saint Petersburg
country: Russian Federation
facility: RU1028
city: Saint Petersburg
country: Russian Federation
facility: RU1030
city: Saint Petersburg
country: Russian Federation
facility: RU1031
city: Saint Petersburg
country: Russian Federation
facility: RU1049
city: Saint Petersburg
country: Russian Federation
facility: RU1052
city: Saint Petersburg
country: Russian Federation
facility: RU1056
city: Yaroslavl
country: Russian Federation
facility: RU1050
city: Belgrade
country: Serbia
facility: RS1008
city: Belgrade
country: Serbia
facility: RS1010
city: Belgrad
country: Serbia
facility: RS1012
city: Kovin
country: Serbia
facility: RS1001
city: Kragujevac
country: Serbia
facility: RS1011
city: Kragujevac
country: Serbia
facility: RS1016
city: Kragujevac
country: Serbia
facility: RS1017
city: Novi Kneževac
country: Serbia
facility: RS1009
city: Bratislava
country: Slovakia
facility: SK1014
city: Bratislava
country: Slovakia
facility: SK1024
city: Zlaté Moravce
country: Slovakia
facility: SK1026
city: Barcelona
country: Spain
facility: ES1047
city: Málaga
country: Spain
facility: ES1008
city: Oviedo
country: Spain
facility: ES1048
city: Kharkiv
country: Ukraine
facility: UA1017
city: Kharkiv
country: Ukraine
facility: UA1035
city: Kherson
country: Ukraine
facility: UA1029
city: Kiev
country: Ukraine
facility: UA1027
city: Kiev
country: Ukraine
facility: UA1028
city: Kiev
country: Ukraine
facility: UA1030
city: Kiev
country: Ukraine
facility: UA1031
city: Lviv
country: Ukraine
facility: UA1033
city: Odesa
country: Ukraine
facility: UA1020
city: Odessa
country: Ukraine
facility: UA1019
city: Oleksandrivka
country: Ukraine
facility: UA1032
city: Poltava
country: Ukraine
facility: UA1001
city: Vinnitsa
country: Ukraine
facility: UA1036
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.