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出境医 / 临床实验 / Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

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

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lu AF11167 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 14, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Lu AF11167 Drug: Lu AF11167
Lu AF11167 - 2 or 4 mg/day; tablets, orally

Outcome Measures
Primary Outcome Measures :
  1. Number of participants with Treatment-Emergent Adverse Events [ Time Frame: 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 :
  1. Change in Brief Negative Symptom Scale (BNSS) total score [ Time Frame: 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.

  2. Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score [ Time Frame: 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.

  3. Change in PANSS Negative subscale score [ Time Frame: 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.

  4. Change in CGI-SCH-S negative symptoms score [ Time Frame: 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.

  5. CGI-SCH-DC negative symptoms score [ Time Frame: 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.

  6. CGI-SCH-DC negative symptoms response [ Time Frame: 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Locations
Show Show 30 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE April 22, 2019
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
Number of participants with Treatment-Emergent Adverse Events [ Time Frame: From baseline week 24 ]
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Change in Brief Negative Symptom Scale (BNSS) total score [ Time Frame: 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 Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score [ Time Frame: 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 PANSS Negative subscale score [ Time Frame: 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 CGI-SCH-S negative symptoms score [ Time Frame: 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.
  • CGI-SCH-DC negative symptoms score [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
Official Title  ICMJE Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Lu AF11167
Lu AF11167 - 2 or 4 mg/day; tablets, orally
Study Arms  ICMJE Experimental: Lu AF11167
Intervention: Drug: Lu AF11167
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 21, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
240
Actual Study Completion Date  ICMJE September 14, 2020
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Estonia,   Germany,   Hungary,   Latvia,   Poland,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929497
Other Study ID Numbers  ICMJE 17972B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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