Back to resultsFlexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lu AF11167
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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
Sites / Locations
- Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
- MHAT Dr. Hristo Stambolski (BG0007)
- First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
- UMHAT Dr.Georgi Stranski EAD (BG0006)
- State Psychiatric Hospital - Sevlievo (BG0009)
- Medical Center INTERMEDICA (BG0003)
- DCC Mladost-M (BG0004)
- Med Centre Medical plus (BG0008)
- DCC Mladost-M Varna OOD (BG0005)
- Mental Health Center-Vratsa EOOD (BG0002)
- Marienthali Kliinik (EE0001)
- OU Jaanson & Laane (EE0002)
- Office of Dr.Kirsten Hahn MD (DE0002)
- Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)
- Bugat Pal Hospital (HU0008)
- Dr Mathe es Tarsa Bt (HU0001)
- Javorszky Odon Hospital (HU0004)
- Hospital Gintermuiza (LV0001)
- Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
- Sigulda Hospital Outpatient Clinic (LV0006)
- Syntonia Sp. z o.o. (PL0002)
- Si Inpn Namsu (Ua0003)
- Si Inpn Namsu (Ua0008)
- Kherson Regional Psychiatric Hospital (UA0009)
- Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
- Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)
- "Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)
- Odessa Regional Medical Centre of Mental Health (UA0006)
- Ukrainian Medical Stomatological Academy (UA0001)
- Vinnitsa National Medical University (UA0002)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lu AF11167
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03929497
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy based on the interim analysis in the 17972A study
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lu AF11167
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lu AF11167
Intervention Description
Lu AF11167 - 2 or 4 mg/day; tablets, orally
Primary Outcome Measure Information:
Title
Number of participants with Treatment-Emergent Adverse Events
Description
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)
Time Frame
From baseline week 24
Secondary Outcome Measure Information:
Title
Change in Brief Negative Symptom Scale (BNSS) total score
Description
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.
Time Frame
from baseline to Week 24
Title
Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score
Description
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.
Time Frame
from baseline to Week 24
Title
Change in PANSS Negative subscale score
Description
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.
Time Frame
from baseline to Week 24
Title
Change in CGI-SCH-S negative symptoms score
Description
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.
Time Frame
from baseline to Week 24
Title
CGI-SCH-DC negative symptoms score
Description
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.
Time Frame
at Week 24
Title
CGI-SCH-DC negative symptoms response
Description
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.
Time Frame
at Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
City
Bourgas
Country
Bulgaria
Facility Name
MHAT Dr. Hristo Stambolski (BG0007)
City
Kazanlak
Country
Bulgaria
Facility Name
First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
City
Novi Iskar
Country
Bulgaria
Facility Name
UMHAT Dr.Georgi Stranski EAD (BG0006)
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
State Psychiatric Hospital - Sevlievo (BG0009)
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Medical Center INTERMEDICA (BG0003)
City
Sofia
Country
Bulgaria
Facility Name
DCC Mladost-M (BG0004)
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Med Centre Medical plus (BG0008)
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
DCC Mladost-M Varna OOD (BG0005)
City
Varna
Country
Bulgaria
Facility Name
Mental Health Center-Vratsa EOOD (BG0002)
City
Vratsa
Country
Bulgaria
Facility Name
Marienthali Kliinik (EE0001)
City
Tallin
Country
Estonia
Facility Name
OU Jaanson & Laane (EE0002)
City
Tartu
Country
Estonia
Facility Name
Office of Dr.Kirsten Hahn MD (DE0002)
City
Berlin
Country
Germany
Facility Name
Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Bugat Pal Hospital (HU0008)
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Dr Mathe es Tarsa Bt (HU0001)
City
Kalocsa
Country
Hungary
Facility Name
Javorszky Odon Hospital (HU0004)
City
Vác
Country
Hungary
Facility Name
Hospital Gintermuiza (LV0001)
City
Jelgava
Country
Latvia
Facility Name
Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
City
Riga
Country
Latvia
Facility Name
Sigulda Hospital Outpatient Clinic (LV0006)
City
Sigulda
Country
Latvia
Facility Name
Syntonia Sp. z o.o. (PL0002)
City
Pruszcz Gdański
ZIP/Postal Code
83000
Country
Poland
Facility Name
Si Inpn Namsu (Ua0003)
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Si Inpn Namsu (Ua0008)
City
Kharkiv
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital (UA0009)
City
Kherson
Country
Ukraine
Facility Name
Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
City
Kiev
Country
Ukraine
Facility Name
Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)
City
Kropyvnytskyi
Country
Ukraine
Facility Name
"Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)
City
Kyiv
ZIP/Postal Code
1030
Country
Ukraine
Facility Name
Odessa Regional Medical Centre of Mental Health (UA0006)
City
Odessa
Country
Ukraine
Facility Name
Ukrainian Medical Stomatological Academy (UA0001)
City
Poltava
Country
Ukraine
Facility Name
Vinnitsa National Medical University (UA0002)
City
Vinnytsia
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
35704951
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.
Results Reference
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Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
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