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Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Sertindole
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Sertindole, Safety study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participation in the previous SCoP study, 99824
  • Still fulfils the EU SPC requirements for Sertindole

Exclusion Criteria:

  • Withdrawn before the end of the SCoP study, 99824
  • Become homeless
  • Participation in another clinical trial at the same time
  • Unlikely to comply with the clinical study protocol or is unsuitable for any reason

Sites / Locations

  • FR002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sertindole

Arm Description

Outcomes

Primary Outcome Measures

All serious adverse events reported; visits scheduled every 3 months

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
November 7, 2016
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00763438
Brief Title
Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
Official Title
A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.
Detailed Description
Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Sertindole, Safety study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertindole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sertindole
Intervention Description
Flexible dose
Primary Outcome Measure Information:
Title
All serious adverse events reported; visits scheduled every 3 months
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in the previous SCoP study, 99824 Still fulfils the EU SPC requirements for Sertindole Exclusion Criteria: Withdrawn before the end of the SCoP study, 99824 Become homeless Participation in another clinical trial at the same time Unlikely to comply with the clinical study protocol or is unsuitable for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
FR002
City
Allonnes
ZIP/Postal Code
72703
Country
France

12. IPD Sharing Statement

Available IPD and Supporting Information:
Available IPD/Information Type
EMA EudraCT Results
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-002160-10/results
Available IPD/Information Identifier
2007-002160-10

Learn more about this trial

Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

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