Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures

NCT ID: NCT00771927

Last Updated: 2014-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1005 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-03-31

Brief Summary

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SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.

Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lacosamide

Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat

Lacosamide

Intervention Type DRUG

Vimpat was used as per site routine practices, and in-line with the marketing authorization.

Other AED

Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy

No interventions assigned to this group

Interventions

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Lacosamide

Vimpat was used as per site routine practices, and in-line with the marketing authorization.

Intervention Type DRUG

Other Intervention Names

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Vimpat®

Eligibility Criteria

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Inclusion Criteria

* This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy
* Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study
* The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study

Exclusion Criteria

* N/A
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Bron, , France

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Dijon, , France

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La Tronche, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Saint-Brieuc, , France

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Tain-l'Hermitage, , France

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Aschaffenburg, , Germany

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Bad Berka, , Germany

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Berlin, , Germany

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Bernau, , Germany

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Bielefeld, , Germany

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Bonn, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Jena, , Germany

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Kehl-Kork, , Germany

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Kiel, , Germany

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Koningstein-Falkenstein, , Germany

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Krefeld, , Germany

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Mainz, , Germany

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Marburg, , Germany

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München, , Germany

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Münster, , Germany

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Neuburg am Inn, , Germany

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Neukirchen-Vluyn, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Potsdam, , Germany

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Radeberg, Sachsen, , Germany

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Ravensburg, , Germany

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Rotenburg (Wümme), , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Vogtareuth, , Germany

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Westerstede, , Germany

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Blaricum, , Netherlands

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Heeze, , Netherlands

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Nijmegen, , Netherlands

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Barcelona, , Spain

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El Vendrell, , Spain

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Plymouth, Devon, United Kingdom

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Fulwood, Preston, Lancashire, United Kingdom

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Bangor, , United Kingdom

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Birmingham, , United Kingdom

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Cardiff, , United Kingdom

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Dundee, , United Kingdom

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Edinburgh, , United Kingdom

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Leeds, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Middlesbrough, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Countries

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France Germany Netherlands Spain United Kingdom

Related Links

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Other Identifiers

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SP0942

Identifier Type: -

Identifier Source: org_study_id

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