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

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Lu AF11167

• Registration Number: NCT03929497
• Lead Sponsor: H. Lundbeck A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Status Verified: 2020-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-14
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF11167	Lu AF11167	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment-Emergent Adverse Events	From baseline week 24	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)

Secondary Outcome Measures

Name	Time	Method
Change in PANSS Negative subscale score	from baseline to Week 24	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.
Change in Brief Negative Symptom Scale (BNSS) total score	from baseline to Week 24	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.
Change in CGI-SCH-S negative symptoms score	from baseline to Week 24	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.
Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score	from baseline to Week 24	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.
CGI-SCH-DC negative symptoms score	at Week 24	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	at Week 24	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.

Trial Locations

Locations (30)

First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010); 🇧🇬 Novi Iskar, Bulgaria

OU Jaanson & Laane (EE0002); 🇪🇪 Tartu, Estonia

Dr Mathe es Tarsa Bt (HU0001); 🇭🇺 Kalocsa, Hungary

Si Inpn Namsu (Ua0003); 🇺🇦 Kharkiv, Ukraine

Odessa Regional Medical Centre of Mental Health (UA0006); 🇺🇦 Odessa, Ukraine

Vinnitsa National Medical University (UA0002); 🇺🇦 Vinnytsia, Ukraine

Ukrainian Medical Stomatological Academy (UA0001); 🇺🇦 Poltava, Ukraine

Syntonia Sp. z o.o. (PL0002); 🇵🇱 Pruszcz Gdański, Poland

Hospital Gintermuiza (LV0001); 🇱🇻 Jelgava, Latvia

Riga Centre Of Psychiatry And Addiction Disorders (LV0002); 🇱🇻 Riga, Latvia

Kherson Regional Psychiatric Hospital (UA0009); 🇺🇦 Kherson, Ukraine

"Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007); 🇺🇦 Kyiv, Ukraine

Bugat Pal Hospital (HU0008); 🇭🇺 Gyöngyös, Hungary

Si Inpn Namsu (Ua0008); 🇺🇦 Kharkiv, Ukraine

Javorszky Odon Hospital (HU0004); 🇭🇺 Vác, Hungary

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

Office of Dr.Kirsten Hahn MD (DE0002); 🇩🇪 Berlin, Germany

Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001); 🇧🇬 Bourgas, Bulgaria

MHAT Dr. Hristo Stambolski (BG0007); 🇧🇬 Kazanlak, Bulgaria

UMHAT Dr.Georgi Stranski EAD (BG0006); 🇧🇬 Pleven, Bulgaria

State Psychiatric Hospital - Sevlievo (BG0009); 🇧🇬 Sevlievo, Bulgaria

DCC Mladost-M (BG0004); 🇧🇬 Varna, Bulgaria

Medical Center INTERMEDICA (BG0003); 🇧🇬 Sofia, Bulgaria

Med Centre Medical plus (BG0008); 🇧🇬 Varna, Bulgaria

Mental Health Center-Vratsa EOOD (BG0002); 🇧🇬 Vratsa, Bulgaria

DCC Mladost-M Varna OOD (BG0005); 🇧🇬 Varna, Bulgaria

Marienthali Kliinik (EE0001); 🇪🇪 Tallin, Estonia

Sigulda Hospital Outpatient Clinic (LV0006); 🇱🇻 Sigulda, Latvia

Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005); 🇭🇺 Budapest, Hungary