SchizophreniaPhase 2NCT03929497
Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms
A Phase 2 study testing Lu AF11167 in people with Schizophrenia, run by H. Lundbeck A/S at 30 sites in 7 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lu AF11167
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 22 Apr 2019to 14 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
Bulgaria10 sites
Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
Burgas
MHAT Dr. Hristo Stambolski (BG0007)
Kazanlak
First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
Novi Iskar
UMHAT Dr.Georgi Stranski EAD (BG0006)
Pleven, 5800
State Psychiatric Hospital - Sevlievo (BG0009)
Sevlievo, 5400
Medical Center INTERMEDICA (BG0003)
Sofia
DCC Mladost-M (BG0004)
Varna, 9000
Med Centre Medical plus (BG0008)
Varna, 9000
DCC Mladost-M Varna OOD (BG0005)
Varna
Mental Health Center-Vratsa EOOD (BG0002)
Vratsa
Ukraine9 sites
Si Inpn Namsu (Ua0003)
Kharkiv, 61068
Si Inpn Namsu (Ua0008)
Kharkiv
Kherson Regional Psychiatric Hospital (UA0009)
Kherson
Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
Kiev
Regional Clinical Psychiatry Hospital of Kirovograd Regional Council, Donetsk National Medical University (UA0004)
Kropyvnytskyi
"Kyiv Railway Clinical Hospital ¿1 of Branch ""Health Center"" of the Public joint stock company ""Ukrainian Railway"", psychoneurological department" (UA0007)
Kyiv, 1030
Odessa Regional Medical Centre of Mental Health (UA0006)
Odesa
Ukrainian Medical Stomatological Academy (UA0001)
Poltava
Vinnitsa National Medical University (UA0002)
Vinnytsia
Hungary4 sites
Semmelweis Egyetem Neurologiai Klinika-Semmelweis University (HU0005)
Budapest, 1083
Bugat Pal Hospital (HU0008)
Gyöngyös, 3200
Dr Mathe es Tarsa Bt (HU0001)
Kalocsa
Javorszky Odon Hospital (HU0004)
Vác
Latvia3 sites
Hospital Gintermuiza (LV0001)
Jelgava
Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
Riga
Sigulda Hospital Outpatient Clinic (LV0006)
Sigulda
Estonia2 sites
Marienthali Kliinik (EE0001)
Tallinn
OU Jaanson & Laane (EE0002)
Tartu
About this study
Official title: 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
- Conditions
- Schizophrenia
- Being tested
- Lu AF11167
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF11167Drug
Lu AF11167 - 2 or 4 mg/day; tablets, orally
| Study group | Role | What they receive |
|---|---|---|
| Lu AF11167 | Experimental | Not described Receives: Drug: Lu AF11167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline week 24
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start22 Apr 2019
- Primary completion1 Sep 2020
- Study completion14 Sep 2020
Why it stopped: Lack of efficacy based on the interim analysis in the 17972A study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929497
- Sponsor's protocol ID
- 17972B
- Status last verified
- Sep 2020
- First submitted
- 24 Apr 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35704951
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Flexible-dose, Long-term Safety Extension Study of Lu AF11167 in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03929497
- Acronym / sponsor ID
- 17972B
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy based on the interim analysis in the 17972A study
- Enrolment
- 96 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF11167 | Experimental | Drug: Lu AF11167 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF11167Lu AF11167 - 2 or 4 mg/day; tablets, orally | Drug | Lu AF11167 |
Primary outcome
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)
6 secondary outcomes
Change in Brief Negative Symptom Scale (BNSS) total score
Time frame: from baseline to Week 24
Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score
Time frame: from baseline to Week 24
Change in PANSS Negative subscale score
Time frame: from baseline to Week 24
Change in CGI-SCH-S negative symptoms score
Time frame: from baseline to Week 24
CGI-SCH-DC negative symptoms score
Time frame: at Week 24
CGI-SCH-DC negative symptoms response
Time frame: at Week 24
Results and safety
The study was stopped early (reason given: Lack of efficacy based on the interim analysis in the 17972A study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 35704951Meyer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AF11167 in people with Schizophrenia, run by H. Lundbeck A/S at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Bulgaria, Ukraine, Hungary, Latvia, Estonia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy based on the interim analysis in the 17972A study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-Emergent Adverse Events (time frame: From baseline week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.