SchizophreniaPhase 3DebutNCT02892422
Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
A Phase 3 study testing Lu AF35700 in people with Schizophrenia, run by H. Lundbeck A/S at 102 sites in 13 countries.
Trial summary
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700. 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 AF35700
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 102 sitesin 13 countries
- Study dates
- Aug 2016to 10 Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For 16159A-patients
- The patient has completed Study 16159A.
- The patient is able to read and understand the Informed Consent Form.
- The patient has signed the Informed Consent Form specific for Study 16159B.
- The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- For 16323A-patients
Show all 21Show fewer
- The patient has completed the dosing period of Study 16323A.
- The patient is able to read and understand the Informed Consent Form.
- The patient has signed the Informed Consent Form specific Study 16159B.
- The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
- The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- For Other Patients
- The patient has schizophrenia, diagnosed according to DSM-5™.
- The patient is a man or woman, aged ≥18 years.
- The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
- The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits.
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4.
- The patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons:
- lack of adequate response to his or her current antipsychotic medication;
- poor tolerability to his or her current antipsychotic medication;
- unwillingness of the patient to adhere to his or her current antipsychotic medication.
Who cannot join
- For 16159A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- For 16323A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
Show all 13Show fewer
- For Other Patients
- The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
- The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
- The patient is treated with clozapine at the time of the Screening Visit.
- The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
102 sites in 13 countries.
102 sites in 13 countries
United States32 sites
US1403
Atlanta, Georgia, 30328
US1009
Atlanta, Georgia, 30331
US1451
Austin, Texas, 78754-5122
US1018
Bellflower, California
US1426
Berlin, New Jersey, 08009
US1390
Charlotte, North Carolina, 28204-3110
US1046
Chicago, Illinois, 60640
US1062
Costa Mesa, California, 92626
US1463
Culver City, California
US1065
Dallas, Texas, 75243
US1399
Escondido, California, 91945
US1086
Flowood, Mississippi, 39232
US1244
Fresh Meadows, New York, 11432
US1104
Garden Grove, California, 92845
US1423
Hoffman Estates, Illinois, 60169-1067
US1444
Las Vegas, Nevada, 89102-1943
US1318
Lauderhill, Florida, 33319
US1130
Miami, Florida, 33122
US1114
National City, California, 91950
US1394
New York, New York, 10032
US1416
New York, New York, 10035-6000
US1124
Norristown, Pennsylvania, 19403
US1129
North Miami, Florida, 33161-5834
US1402
Oakland Park, Florida, 33334-4400
US1459
Oceanside, California
US1368
Orange, California, 92868
US1171
Rochester, New York, 14618
US1391
San Bernardino, California, 92408-3332
US1398
Shreveport, Louisiana, 71101-4603
US1404
Shreveport, Louisiana, 71104-2136
US1190
Staten Island, New York, 10312-6501
US1392
Torrance, California, 90502-4432
Russia14 sites
RU1009
Arkhangelsk
RU1021
Gatchina
RU1006
Moscow
RU1051
Moscow
RU1055
Moscow
RU1053
Roshchino
RU1023
Saint Petersburg
RU1028
Saint Petersburg
RU1030
Saint Petersburg
RU1031
Saint Petersburg
RU1049
Saint Petersburg
RU1052
Saint Petersburg
RU1056
Saint Petersburg
RU1050
Yaroslavl
Ukraine13 sites
UA1017
Kharkiv
UA1035
Kharkiv
UA1029
Kherson
UA1027
Kiev
UA1028
Kiev
UA1030
Kiev
UA1031
Kiev
UA1033
Lviv
UA1019
Odesa
UA1020
Odesa
UA1032
Oleksandrivka
UA1001
Poltava
UA1036
Vinnitsa
Bulgaria9 sites
BG1030
Burgas
BG1028
Kazanlak
BG1003
Lovech
BG1008
Plovdiv
BG1024
Sofia
BG1026
Sofia
BG1034
Varna
BG1029
Veliko Tarnovo
BG1027
Vratsa
Mexico8 sites
MX1024
Durango
MX1011
Guadalajara
MX1021
Guadalajara
MX1022
Guadalajara
MX1020
Mexico City
MX1005
Monterrey
MX1007
Monterrey
MX1015
Monterrey
Serbia8 sites
RS1008
Belgrade
RS1010
Belgrade
RS1012
Belgrade
RS1001
Kovin
RS1011
Kragujevac
RS1016
Kragujevac
RS1017
Kragujevac
RS1009
Novi Kneževac
Poland5 sites
PL1043
Bialystok
PL1060
Lodz
PL1058
Pruszcz Gdański
PL1059
Torun
PL1051
Wroclaw
About this study
Official title: Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
Read the detailed description
Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.
- Conditions
- Schizophrenia
- Being tested
- Lu AF35700
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700Drug
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)
Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
| Study group | Role | What they receive |
|---|---|---|
| Flexible-dose of Lu AF35700 | Experimental | Not described Receives: Drug: Lu AF35700 |
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 (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
Measured: From dosing to end of study (57 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 528 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
- NCT02892422
- Sponsor's protocol ID
- 16159B
- Other IDs
- 2015-003284-11, 2015
- Acronym
- Debut
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2016
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.
PubMed 36115192
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02892422
- Acronym / sponsor ID
- Debut / 16159B
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
Detailed description
Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible-dose of Lu AF35700 | Experimental | Drug: Lu AF35700 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For 16159A-patients
- The patient has completed Study 16159A.
- The patient is able to read and understand the Informed Consent Form.
- The patient has signed the Informed Consent Form specific for Study 16159B.
- The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
Key exclusion criteria (13 listed)
- For 16159A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
- The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- For 16323A-patients
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
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 AF35700Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study | Drug | Flexible-dose of Lu AF35700 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From dosing to end of study (57 weeks)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36115192Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.
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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
102 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lu AF35700 in people with Schizophrenia, run by H. Lundbeck A/S at 102 sites in 13 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 21 inclusion and 13 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: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Russia, Ukraine, Bulgaria, Mexico and 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Safety and Tolerability) (time frame: From dosing to end of study (57 weeks)). 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 NCT02892422, 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 26 Oct 2020.