Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia (Debut)

September 30, 2020 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

528

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • BG1030
      • Kazanlak, Bulgaria
        • BG1028
      • Lovech, Bulgaria
        • BG1003
      • Plovdiv, Bulgaria
        • BG1008
      • Sofia, Bulgaria
        • BG1024
      • Sofia, Bulgaria
        • BG1026
      • Varna, Bulgaria
        • BG1034
      • Veliko Tŭrnovo, Bulgaria
        • BG1029
      • Vratsa, Bulgaria
        • BG1027
  • Canada
      • Penticton, Canada
        • CA1029
  • Czechia
      • Brno, Czechia
        • CZ1023
      • Brno, Czechia
        • CZ1032
      • Lnáře, Czechia
        • CZ1013
      • Praha, Czechia
        • CZ1038
  • Estonia
      • Tallinn, Estonia
        • EE1007
  • Mexico
      • Durango, Mexico
        • MX1024
      • Guadalajara, Mexico
        • MX1011
      • Guadalajara, Mexico
        • MX1022
      • Guadalajara, Mexico
        • MX1021
      • Mexico City, Mexico
        • MX1020
      • Monterrey, Mexico
        • MX1005
      • Monterrey, Mexico
        • MX1007
      • Monterrey, Mexico
        • MX1015
  • Poland
      • Bialystok, Poland
        • PL1043
      • Pruszcz Gdanski, Poland
        • PL1058
      • Toruń, Poland
        • PL1059
      • Wrocław, Poland
        • PL1051
      • Łódź, Poland
        • PL1060
  • Romania
      • Bucharest, Romania
        • RO1024
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • RU1009
      • Gatchina, Russian Federation
        • RU1021
      • Moscow, Russian Federation
        • RU1006
      • Moscow, Russian Federation
        • RU1051
      • Moscow, Russian Federation
        • RU1055
      • Roshchino, Russian Federation
        • RU1053
      • Saint Petersburg, Russian Federation
        • RU1023
      • Saint Petersburg, Russian Federation
        • RU1028
      • Saint Petersburg, Russian Federation
        • RU1030
      • Saint Petersburg, Russian Federation
        • RU1031
      • Saint Petersburg, Russian Federation
        • RU1052
      • Saint Petersburg, Russian Federation
        • RU1056
      • Saint Petersburg, Russian Federation
        • RU1049
      • Yaroslavl, Russian Federation
        • RU1050
  • Serbia
      • Belgrad, Serbia
        • RS1012
      • Belgrade, Serbia
        • RS1008
      • Belgrade, Serbia
        • RS1010
      • Kovin, Serbia
        • RS1001
      • Kragujevac, Serbia
        • RS1011
      • Kragujevac, Serbia
        • RS1016
      • Kragujevac, Serbia
        • RS1017
      • Novi Kneževac, Serbia
        • RS1009
  • Slovakia
      • Bratislava, Slovakia
        • SK1014
      • Bratislava, Slovakia
        • SK1024
      • Zlaté Moravce, Slovakia
        • SK1026
  • Spain
      • Barcelona, Spain
        • ES1047
      • Málaga, Spain
        • ES1008
      • Oviedo, Spain
        • ES1048
  • Ukraine
      • Kharkiv, Ukraine
        • UA1017
      • Kharkiv, Ukraine
        • UA1035
      • Kherson, Ukraine
        • UA1029
      • Kiev, Ukraine
        • UA1027
      • Kiev, Ukraine
        • UA1030
      • Kiev, Ukraine
        • UA1028
      • Kiev, Ukraine
        • UA1031
      • Lviv, Ukraine
        • UA1033
      • Odesa, Ukraine
        • UA1020
      • Odessa, Ukraine
        • UA1019
      • Oleksandrivka, Ukraine
        • UA1032
      • Poltava, Ukraine
        • UA1001
      • Vinnitsa, Ukraine
        • UA1036
  • United States
    • California
      • Bellflower, California, United States
        • US1018
      • Costa Mesa, California, United States, 92626
        • US1062
      • Culver City, California, United States
        • US1463
      • Escondido, California, United States, 91945
        • US1399
      • Garden Grove, California, United States, 92845
        • US1104
      • National City, California, United States, 91950
        • US1114
      • Oceanside, California, United States
        • US1459
      • Orange, California, United States, 92868
        • US1368
      • San Bernardino, California, United States, 92408-3332
        • US1391
      • Torrance, California, United States, 90502-4432
        • US1392
    • Florida
      • Lauderhill, Florida, United States, 33319
        • US1318
      • Miami, Florida, United States, 33122
        • US1130
      • North Miami, Florida, United States, 33161-5834
        • US1129
      • Oakland Park, Florida, United States, 33334-4400
        • US1402
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • US1403
      • Atlanta, Georgia, United States, 30331
        • US1009
    • Illinois
      • Chicago, Illinois, United States, 60640
        • US1046
      • Hoffman Estates, Illinois, United States, 60169-1067
        • US1423
    • Louisiana
      • Shreveport, Louisiana, United States, 71101-4603
        • US1398
      • Shreveport, Louisiana, United States, 71104-2136
        • US1404
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • US1086
    • Nevada
      • Las Vegas, Nevada, United States, 89102-1943
        • US1444
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • US1426
    • New York
      • Fresh Meadows, New York, United States, 11432
        • US1244
      • New York, New York, United States, 10032
        • US1394
      • New York, New York, United States, 10035-6000
        • US1416
      • Rochester, New York, United States, 14618
        • US1171
      • Staten Island, New York, United States, 10312-6501
        • US1190
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-3110
        • US1390
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19403
        • US1124
    • Texas
      • Austin, Texas, United States, 78754-5122
        • US1451
      • Dallas, Texas, United States, 75243
        • US1065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

- 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

  • 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.

Exclusion Criteria:

- 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flexible-dose of Lu AF35700
Drug: Lu AF35700

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

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)
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)
From dosing to end of study (57 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16159B
  • 2015-003284-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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