Clinical trial NCT03929497: Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
Official title: Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-04-26
Enrollment: 96
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: A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period


Eligibility 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.

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 in- and exclusion criteria may apply

Primary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events
timeFrame: From baseline week 24
Secondary outcomes:
measure: Change in Brief Negative Symptom Scale (BNSS) total score
timeFrame: from baseline to Week 24
measure: Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score
timeFrame: from baseline to Week 24
measure: Change in PANSS Negative subscale score
timeFrame: from baseline to Week 24
measure: Change in CGI-SCH-S negative symptoms score
timeFrame: from baseline to Week 24
measure: CGI-SCH-DC negative symptoms score
timeFrame: at Week 24
measure: CGI-SCH-DC negative symptoms response
timeFrame: at Week 24
Other outcomes:
Locations:
city: Bourgas
country: Bulgaria
facility: Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
city: Kazanlak
country: Bulgaria
facility: MHAT Dr. Hristo Stambolski (BG0007)
city: Novi Iskar
country: Bulgaria
facility: First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
city: Pleven
country: Bulgaria
facility: UMHAT Dr.Georgi Stranski EAD (BG0006)
city: Sevlievo
country: Bulgaria
facility: State Psychiatric Hospital - Sevlievo (BG0009)
city: Sofia
country: Bulgaria
facility: Medical Center INTERMEDICA (BG0003)
city: Varna
country: Bulgaria
facility: DCC Mladost-M (BG0004)
city: Varna
country: Bulgaria
facility: Med Centre Medical plus (BG0008)
city: Varna
country: Bulgaria
facility: DCC Mladost-M Varna OOD (BG0005)
city: Vratsa
country: Bulgaria
facility: Mental Health Center-Vratsa EOOD (BG0002)
city: Tallin
country: Estonia
facility: Marienthali Kliinik (EE0001)
city: Tartu
country: Estonia
facility: OU Jaanson & Laane (EE0002)
city: Berlin
country: Germany
facility: Office of Dr.Kirsten Hahn MD (DE0002)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)
city: Gyöngyös
country: Hungary
facility: Bugat Pal Hospital (HU0008)
city: Kalocsa
country: Hungary
facility: Dr Mathe es Tarsa Bt (HU0001)
city: Vác
country: Hungary
facility: Javorszky Odon Hospital (HU0004)
city: Jelgava
country: Latvia
facility: Hospital Gintermuiza (LV0001)
city: Riga
country: Latvia
facility: Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
city: Sigulda
country: Latvia
facility: Sigulda Hospital Outpatient Clinic (LV0006)
city: Pruszcz Gdański
country: Poland
facility: Syntonia Sp. z o.o. (PL0002)
city: Kharkiv
country: Ukraine
facility: Si Inpn Namsu (Ua0003)
city: Kharkiv
country: Ukraine
facility: Si Inpn Namsu (Ua0008)
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital (UA0009)
city: Kiev
country: Ukraine
facility: Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
city: Kropyvnytskyi
country: Ukraine
facility: Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)
city: Kyiv
country: Ukraine
facility: "Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)
city: Odessa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health (UA0006)
city: Poltava
country: Ukraine
facility: Ukrainian Medical Stomatological Academy (UA0001)
city: Vinnytsia
country: Ukraine
facility: Vinnitsa National Medical University (UA0002)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, Zambori J, Buller R, der Goltz CV. A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia. Eur Neuropsychopharmacol. 2022 Aug;61:4-14. doi: 10.1016/j.euroneuro.2022.05.009. Epub 2022 Jun 12.