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

NCT00771927 | Completed Results

• 1 other identifier: SP0942
• Study Type: observational
• Target: 1,005
• Locations: 5 countries
• Sites: 62

Brief Summary

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.

Conditions

Epilepsies, Partial

Keywords

Vimpat®; Lacosamide; LCM; epilepsy; epilepsies; seizure; partial seizure; partial onset; seizure disorder; single seizure; motor seizure; convulsions; add-on; AED; anti-epileptic; anti-epileptic drug; seizure control; open-label; post authorization; PASS; late stage; trial; study; phase 4; phase IV

Outcome Measures

Primary Outcomes (1)

• The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study

  Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.

  From Baseline up to 12 months

Secondary Outcomes (1)

• The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study

  From Baseline up to 12 months

Study Arms (2)

Lacosamide

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

Drug: Lacosamide

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

Interventions

Lacosamide DRUG

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

Also known as: Vimpat®

Lacosamide

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Institutions, hospitals, primary care clinics and community based

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (62)

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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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Related Links

• Product information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 27, 2014
• Results First Posted: April 22, 2013

Record last verified: 2013-05

Locations

ES (2); NL (3); DE (35); FR (8); GB (14)