A prospective, open-label, single arm, multinational, multi-centre, flexible dose, extension study of the SCoP 99824 with sertindole for patients suffering from schizophrenia

Phase 1

• Conditions: Patients suffering from schizophrenia, according to the ICD-10, DSM-IV or regional classification criteria; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2007-002160-10-FR
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-07-26
• Study Start: 2007-10-19
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.The patient and/or legally acceptable representative is able to read and understand the Patient Information Sheet for Study 12009A.
2.The patient has signed the Informed Consent Form for Study 12009A.
3.The patient has taken part in SCoP Study 99824 study.
4.The patient still fulfils the EU SPC requirements for sertindole, including pregnancy exclusion and ECG parameters warnings.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.The patient has withdrawn before the end of SCoP 99824 study.
The patient has become homeless.
3.The patient is going to participate in another clinical trial at the same time.
4.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To permit the sertindole patients who completed the SCoP study 99824 to continue with their sertindole treatment in countries where the medication is not yet adequately available.;Secondary Objective: To monitor the serious adverse events of sertindole under normal conditions of use.;Primary end point(s): Safety: Serious adverse event report (SAEs); no reporting of non-serious adverse events<br>Vital status.