Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

Schizophrenia Clinical Trial

Official title:

Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03929497
• Other study ID #: 17972B
• Status: Terminated
• Phase: Phase 2
• Start date: April 22, 2019
• Est. completion date: September 14, 2020

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: September 14, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lu AF11167
Lu AF11167 - 2 or 4 mg/day; tablets, orally

Locations

Country	Name	City	State
Bulgaria	Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)	Bourgas
Bulgaria	MHAT Dr. Hristo Stambolski (BG0007)	Kazanlak
Bulgaria	First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)	Novi Iskar
Bulgaria	UMHAT Dr.Georgi Stranski EAD (BG0006)	Pleven
Bulgaria	State Psychiatric Hospital - Sevlievo (BG0009)	Sevlievo
Bulgaria	Medical Center INTERMEDICA (BG0003)	Sofia
Bulgaria	DCC Mladost-M (BG0004)	Varna
Bulgaria	DCC Mladost-M Varna OOD (BG0005)	Varna
Bulgaria	Med Centre Medical plus (BG0008)	Varna
Bulgaria	Mental Health Center-Vratsa EOOD (BG0002)	Vratsa
Estonia	Marienthali Kliinik (EE0001)	Tallin
Estonia	OU Jaanson & Laane (EE0002)	Tartu
Germany	Office of Dr.Kirsten Hahn MD (DE0002)	Berlin
Hungary	Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)	Budapest
Hungary	Bugat Pal Hospital (HU0008)	Gyöngyös
Hungary	Dr Mathe es Tarsa Bt (HU0001)	Kalocsa
Hungary	Javorszky Odon Hospital (HU0004)	Vác
Latvia	Hospital Gintermuiza (LV0001)	Jelgava
Latvia	Riga Centre Of Psychiatry And Addiction Disorders (LV0002)	Riga
Latvia	Sigulda Hospital Outpatient Clinic (LV0006)	Sigulda
Poland	Syntonia Sp. z o.o. (PL0002)	Pruszcz Gdanski
Ukraine	Si Inpn Namsu (Ua0003)	Kharkiv
Ukraine	Si Inpn Namsu (Ua0008)	Kharkiv
Ukraine	Kherson Regional Psychiatric Hospital (UA0009)	Kherson
Ukraine	Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)	Kiev
Ukraine	Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)	Kropyvnytskyi
Ukraine	"Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)	Kyiv
Ukraine	Odessa Regional Medical Centre of Mental Health (UA0006)	Odessa
Ukraine	Ukrainian Medical Stomatological Academy (UA0001)	Poltava
Ukraine	Vinnitsa National Medical University (UA0002)	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Germany,  Hungary,  Latvia,  Poland,  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 (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)	From baseline week 24
Secondary	Change in Brief Negative Symptom Scale (BNSS) total score	The BNSS is a brief clinician rating scale, intended to measure negative symptoms. It consists of 13 items organized into 6 subscales: anhedonia, distress, asociality, avolition, blunted affect, and alogia. The items score the impairment. Items 1 to 4 are rated from 0 (Normal) to 6 (Extremely severe) and items 5 to 13 are rated from 0 (No impairment) to 6 (Severe deficit). The BNSS total score is calculated by summing the 13 individual items; subscale scores are calculated by summing the individual items within each subscale. Users of the BNSS should have training in psychiatric interview techniques and have clinical experience working with patients with schizophrenia and related psychotic disorders. The BNSS total scores ranges from 0 to 78.	from baseline to Week 24
Secondary	Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score	The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items: 7 items make up the positive scale (for example: delusions, conceptual disorganization and hallucinatory behaviour), 7 items make up the negative scale (for example: blunted affect, emotional withdrawal and poor rapport) and 16 items make up the general psychopathology scale (for example: somatic concern, anxiety and guilt feelings). Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of all items, and ranges from 30 to 210. Subscale scores are the sum of items within each subscale.	from baseline to Week 24
Secondary	Change in PANSS Negative subscale score	The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items: 7 items make up the positive scale (for example: delusions, conceptual disorganization and hallucinatory behaviour), 7 items make up the negative scale (for example: blunted affect, emotional withdrawal and poor rapport) and 16 items make up the general psychopathology scale (for example: somatic concern, anxiety and guilt feelings). Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of all items, and ranges from 30 to 210. Subscale scores are the sum of items within each subscale.	from baseline to Week 24
Secondary	Change in CGI-SCH-S negative symptoms score	The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-severity of illness symptoms and overall severity are rated on a 7-point scale ranging from 1 (normal - not ill) to 7 (Among the most severely ill). For the first four ratings (positive, negative, depressive, and cognitive symptoms), the assessment should focus on the severity of symptoms only. Additionally, for 'overall severity' rating, both severity of symptoms and interference with functioning should be considered.	from baseline to Week 24
Secondary	CGI-SCH-DC negative symptoms score	The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-degree of change symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of change) and overall ratings of severity and improvement are scored independently and no total score is derived.	at Week 24
Secondary	CGI-SCH-DC negative symptoms response	The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive, and depressive) and the overall severity of the disorder. The CGI-SCH-degree of change symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of change) and overall ratings of severity and improvement are scored independently and no total score is derived.CGI-SCH-DC negative symptoms response is defined as a CGI-SCH-DC negative symptoms score of 1 or 2.	at Week 24