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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002160-10-FR

Enrollment

Registered

2007-10-19

Start date

2007-11-21

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Serdolect Product Name: Serdolect film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SERTINDOLE CAS Number: 106516249 Current Sponsor code: Lu 23-174 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1.The patient has withdrawn before the end of SCoP 99824 study.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.

Design outcomes

Primary

Measure	Time frame
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 Vital status.	—

Measure

Time frame

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 Vital status.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026