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

• Register: EUCTR
• Last refreshed on: 13 October 2020
• Main ID: EUCTR2015-003284-11-EE
• Date of registration: 30/08/2016
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia (Debut)
• Scientific title: Interventional, open-label, flexible-dose, long-term safety study of Lu AF35700 in adult patients with schizophrenia
• Date of first enrolment: 08/09/2016
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003284-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Bulgaria, Canada, Czech Republic, Estonia, Finland, Italy, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, United States

Contacts

• Name: [e-mail]
• Affiliation: H. Lundbeck A/S

• Name: [e-mail]
• Affiliation: H. Lundbeck A/S

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 397
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Treatment-resistant schizophrenia
MedDRA version: 20.0 Level: LLT Classification code 10072913 Term: Treatment-resistant schizophrenia System Organ Class: 100000004873

Intervention(s)

Product Name: AF35700
Product Code: AF35700
Pharmaceutical Form: Tablet
INN or Proposed INN: AF35700
Current Sponsor code: AF35700
Other descriptive name: AF35700
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: AF35700
Product Code: AF35700
Pharmaceutical Form: Tablet
INN or Proposed INN: AF35700
Current Sponsor code: AF35700
Other descriptive name: AF35700
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: AF35700
Product Code: AF35700
Pharmaceutical Form: Tablet
INN or Proposed INN: AF35700
Current Sponsor code: AF35700
Other descriptive name: AF35700
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-

Primary Outcome(s)

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: From dosing to end of study (57 weeks)

Main Objective: To evaluate the safety and tolerability of the long-term treatment with Lu AF35700

Primary end point(s): Safety and tolerability
Based on the Safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, waist circumference and ECG

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

16159B

2015-003284-11-ES

Source(s) of Monetary Support

H. Lundbeck A/S

Ethics review

Status: Approved
Approval date: 11/08/2016
Contact: