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

October 17, 2014 updated by: UCB Pharma

Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
      • Dijon, France
      • La Tronche, France
      • Montpellier, France
      • Nantes, France
      • Paris, France
      • Saint Brieuc, France
      • Tain L'Hermitage, France
  • Germany
      • Aschaffenburg, Germany
      • Bad Berka, Germany
      • Berlin, Germany
      • Bernau, Germany
      • Bielefeld, Germany
      • Bonn, Germany
      • Dresden, Germany
      • Dusseldorf, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Freiburg, Germany
      • Gottingen, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Jena, Germany
      • Kehl-Kork, Germany
      • Kiel, Germany
      • Koningstein-Falkenstein, Germany
      • Krefeld, Germany
      • Mainz, Germany
      • Marburg, Germany
      • Munster, Germany
      • München, Germany
      • Neuburg, Germany
      • Neukirchen-Vluyn, Germany
      • Oldenburg, Germany
      • Osnabruck, Germany
      • Potsdam, Germany
      • Radeberg, Sachsen, Germany
      • Ravensburg, Germany
      • Rotenburg/Wümme, Germany
      • Stuttgart, Germany
      • Ulm, Germany
      • Vogtareuth, Germany
      • Westerstede, Germany
  • Netherlands
      • Blaricum, Netherlands
      • Heeze, Netherlands
      • Nijmegen, Netherlands
  • Spain
      • Barcelona, Spain
      • El Vendrell, Spain
  • United Kingdom
      • Bangor, United Kingdom
      • Birmingham, United Kingdom
      • Cardiff, United Kingdom
      • Dundee, United Kingdom
      • Edinburgh, United Kingdom
      • Leeds, United Kingdom
      • Leicester, United Kingdom
      • London, United Kingdom
      • Middlesborough, United Kingdom
      • Salford, United Kingdom
      • Sheffield, United Kingdom
      • Stoke on Trent, United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom
    • Lancashire
      • Fulwood, Preston, Lancashire, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Institutions, hospitals, primary care clinics and community based

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lacosamide
Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
Drug: Lacosamide
Vimpat was used as per site routine practices, and in-line with the marketing authorization.
Other Names:
  • Vimpat®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From Baseline up to 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From Baseline up to 12 months

Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0942

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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