Clinical trial NCT00771927: Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 1005
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Institutions, hospitals, primary care clinics and community based

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From Baseline up to 12 months
Secondary outcomes:
measure: 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
timeFrame: From Baseline up to 12 months
Other outcomes:
Locations:
city: Bron
country: France
city: Dijon
country: France
city: La Tronche
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Paris
country: France
city: Saint Brieuc
country: France
city: Tain L'Hermitage
country: France
city: Aschaffenburg
country: Germany
city: Bad Berka
country: Germany
city: Berlin
country: Germany
city: Bernau
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Dusseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Freiburg
country: Germany
city: Gottingen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Jena
country: Germany
city: Kehl-Kork
country: Germany
city: Kiel
country: Germany
city: Koningstein-Falkenstein
country: Germany
city: Krefeld
country: Germany
city: Mainz
country: Germany
city: Marburg
country: Germany
city: Munster
country: Germany
city: München
country: Germany
city: Neuburg
country: Germany
city: Neukirchen-Vluyn
country: Germany
city: Oldenburg
country: Germany
city: Osnabruck
country: Germany
city: Potsdam
country: Germany
city: Radeberg, Sachsen
country: Germany
city: Ravensburg
country: Germany
city: Rotenburg/Wümme
country: Germany
city: Stuttgart
country: Germany
city: Ulm
country: Germany
city: Vogtareuth
country: Germany
city: Westerstede
country: Germany
city: Blaricum
country: Netherlands
city: Heeze
country: Netherlands
city: Nijmegen
country: Netherlands
city: Barcelona
country: Spain
city: El Vendrell
country: Spain
city: Plymouth
country: United Kingdom
state: Devon
city: Fulwood, Preston
country: United Kingdom
state: Lancashire
city: Bangor
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Dundee
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stoke on Trent
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: