Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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: |
|
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:
|
LundbeckClinicalTrials@lundbeck.com
|
Address:
|
Ottiliavej 9
2500
Valby
Denmark |
Telephone:
|
4536301311 |
Email:
|
LundbeckClinicalTrials@lundbeck.com |
Affiliation:
|
H. Lundbeck A/S |
|
Name:
|
LundbeckClinicalTrials@lundbeck.com
|
Address:
|
Ottiliavej 9
2500
Valby
Denmark |
Telephone:
|
4536301311 |
Email:
|
LundbeckClinicalTrials@lundbeck.com |
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:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|