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

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

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

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lu AF11167

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Bourgas, Bulgaria
    • Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
  • Kazanlak, Bulgaria
    • MHAT Dr. Hristo Stambolski (BG0007)
  • Novi Iskar, Bulgaria
    • First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
  • Pleven, Bulgaria, 5800
    • UMHAT Dr.Georgi Stranski EAD (BG0006)
  • Sevlievo, Bulgaria, 5400
    • State Psychiatric Hospital - Sevlievo (BG0009)
  • Sofia, Bulgaria
    • Medical Center INTERMEDICA (BG0003)
  • Varna, Bulgaria
    • DCC Mladost-M Varna OOD (BG0005)
  • Varna, Bulgaria, 9000
    • DCC Mladost-M (BG0004)
  • Varna, Bulgaria, 9000
    • Med Centre Medical plus (BG0008)
  • Vratsa, Bulgaria
    • Mental Health Center-Vratsa EOOD (BG0002)
• Estonia
  • Tallin, Estonia
    • Marienthali Kliinik (EE0001)
  • Tartu, Estonia
    • OU Jaanson & Laane (EE0002)
• Germany
  • Berlin, Germany
    • Office of Dr.Kirsten Hahn MD (DE0002)
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)
  • Gyöngyös, Hungary, 3200
    • Bugat Pal Hospital (HU0008)
  • Kalocsa, Hungary
    • Dr Mathe es Tarsa Bt (HU0001)
  • Vác, Hungary
    • Javorszky Odon Hospital (HU0004)
• Latvia
  • Jelgava, Latvia
    • Hospital Gintermuiza (LV0001)
  • Riga, Latvia
    • Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
  • Sigulda, Latvia
    • Sigulda Hospital Outpatient Clinic (LV0006)
• Poland
  • Pruszcz Gdański, Poland, 83000
    • Syntonia Sp. z o.o. (PL0002)
• Ukraine
  • Kharkiv, Ukraine
    • Si Inpn Namsu (Ua0008)
  • Kharkiv, Ukraine, 61068
    • Si Inpn Namsu (Ua0003)
  • Kherson, Ukraine
    • Kherson Regional Psychiatric Hospital (UA0009)
  • Kiev, Ukraine
    • Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
  • Kropyvnytskyi, Ukraine
    • Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)
  • Kyiv, Ukraine, 1030
    • "Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)
  • Odessa, Ukraine
    • Odessa Regional Medical Centre of Mental Health (UA0006)
  • Poltava, Ukraine
    • Ukrainian Medical Stomatological Academy (UA0001)
  • Vinnytsia, Ukraine
    • Vinnitsa National Medical University (UA0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AF11167	Drug: Lu AF11167; Lu AF11167 - 2 or 4 mg/day; tablets, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 17972B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No