Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Schizophrenia Clinical Trial

— Debut  

Official title:

Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892422
• Other study ID #: 16159B
• Secondary ID: 2015-003284-11
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: October 10, 2019

Study information

• Verified date: September 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

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 information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	BG1030	Burgas
Bulgaria	BG1028	Kazanlak
Bulgaria	BG1003	Lovech
Bulgaria	BG1008	Plovdiv
Bulgaria	BG1024	Sofia
Bulgaria	BG1026	Sofia
Bulgaria	BG1034	Varna
Bulgaria	BG1029	Veliko Turnovo
Bulgaria	BG1027	Vratsa
Canada	CA1029	Penticton
Czechia	CZ1023	Brno
Czechia	CZ1032	Brno
Czechia	CZ1013	Lnáre
Czechia	CZ1038	Praha
Estonia	EE1007	Tallinn
Mexico	MX1024	Durango
Mexico	MX1011	Guadalajara
Mexico	MX1021	Guadalajara
Mexico	MX1022	Guadalajara
Mexico	MX1020	Mexico City
Mexico	MX1005	Monterrey
Mexico	MX1007	Monterrey
Mexico	MX1015	Monterrey
Poland	PL1043	Bialystok
Poland	PL1060	Lódz
Poland	PL1058	Pruszcz Gdanski
Poland	PL1059	Torun
Poland	PL1051	Wroclaw
Romania	RO1024	Bucharest
Russian Federation	RU1009	Arkhangel'sk
Russian Federation	RU1021	Gatchina
Russian Federation	RU1006	Moscow
Russian Federation	RU1051	Moscow
Russian Federation	RU1055	Moscow
Russian Federation	RU1053	Roshchino
Russian Federation	RU1023	Saint Petersburg
Russian Federation	RU1028	Saint Petersburg
Russian Federation	RU1030	Saint Petersburg
Russian Federation	RU1031	Saint Petersburg
Russian Federation	RU1049	Saint Petersburg
Russian Federation	RU1052	Saint Petersburg
Russian Federation	RU1056	Saint Petersburg
Russian Federation	RU1050	Yaroslavl
Serbia	RS1012	Belgrad
Serbia	RS1008	Belgrade
Serbia	RS1010	Belgrade
Serbia	RS1001	Kovin
Serbia	RS1011	Kragujevac
Serbia	RS1016	Kragujevac
Serbia	RS1017	Kragujevac
Serbia	RS1009	Novi Kneževac
Slovakia	SK1014	Bratislava
Slovakia	SK1024	Bratislava
Slovakia	SK1026	Zlaté Moravce
Spain	ES1047	Barcelona
Spain	ES1008	Málaga
Spain	ES1048	Oviedo
Ukraine	UA1017	Kharkiv
Ukraine	UA1035	Kharkiv
Ukraine	UA1029	Kherson
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	UA1001	Poltava
Ukraine	UA1036	Vinnitsa
United States	US1009	Atlanta	Georgia
United States	US1403	Atlanta	Georgia
United States	US1451	Austin	Texas
United States	US1018	Bellflower	California
United States	US1426	Berlin	New Jersey
United States	US1390	Charlotte	North Carolina
United States	US1046	Chicago	Illinois
United States	US1062	Costa Mesa	California
United States	US1463	Culver City	California
United States	US1065	Dallas	Texas
United States	US1399	Escondido	California
United States	US1086	Flowood	Mississippi
United States	US1244	Fresh Meadows	New York
United States	US1104	Garden Grove	California
United States	US1423	Hoffman Estates	Illinois
United States	US1444	Las Vegas	Nevada
United States	US1318	Lauderhill	Florida
United States	US1130	Miami	Florida
United States	US1114	National City	California
United States	US1394	New York	New York
United States	US1416	New York	New York
United States	US1124	Norristown	Pennsylvania
United States	US1129	North Miami	Florida
United States	US1402	Oakland Park	Florida
United States	US1459	Oceanside	California
United States	US1368	Orange	California
United States	US1171	Rochester	New York
United States	US1391	San Bernardino	California
United States	US1398	Shreveport	Louisiana
United States	US1404	Shreveport	Louisiana
United States	US1190	Staten Island	New York
United States	US1392	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Estonia,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	From dosing to end of study (57 weeks)