Clinical trial NCT01991041: European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
Official title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lennox-Gastaut Syndrome
Keywords: Lennox-Gastaut Syndrome
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 109
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation in this study will be offered to any patient of four years or older, who has a known diagnosis of LGS, who requires a change in anti-epileptic therapy. This will include patients who are started on rufinamide, as an adjuvant therapy.

Brief summary: This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.


Eligibility criteria: INCLUSION CRITERIA

* Patients will be four years and older
* Patients will have an established diagnosis of Lennox-Gastaut syndrome, and:
* Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences)
* Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity)
* Presence of intellectual / learning disability (a variable degree is permitted)
* Patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. This includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy

EXCLUSION CRITERIA

* Female patients who are pregnant, lactating, or whom are planning to become pregnant
* Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator)
* Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC).

Primary outcomes:
measure: Safety during the use of rufinamide and other anti-epileptic drugs
timeFrame: At least three years
Secondary outcomes:
measure: Long term use of rufinamide, and other anti-epileptic drugs
timeFrame: At least three years
Other outcomes:
Locations:
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Mödling
country: Austria
city: Steyr
country: Austria
city: Wein
country: Austria
city: Wien
country: Austria
city: Copenhagen
country: Denmark
city: Dianalund
country: Denmark
city: Besançon cedex
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris Cedex 15
country: France
city: Paris
country: France
city: Reims Cedex
country: France
city: Strasbourg Cedex
country: France
city: Tain L'Hermitage
country: France
city: Berlin
country: Germany
city: Bernau
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Erlangen
country: Germany
city: Freiburg im Breisgau
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Kehl
country: Germany
city: Kiel
country: Germany
city: Münster
country: Germany
city: Stuttgart
country: Germany
city: Tübingen
country: Germany
city: Vogtareuth
country: Germany
city: Mantova
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Trieste
country: Italy
city: Verona
country: Italy
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Esplugues de Llobregat
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Pamplona
country: Spain
city: Lund
country: Sweden
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: West Yorkshire
country: United Kingdom
Study officials:
References:
citation: Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.