European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01991041
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

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.

Condition or disease
Lennox-Gastaut Syndrome

Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).
Study Start Date : June 2008
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Anti-Epileptic Drugs
Includes those used off label as part of local clinical practice

Primary Outcome Measures :
  1. Safety during the use of rufinamide and other anti-epileptic drugs [ Time Frame: At least three years ]
    Evaluation of the incidence of seizures of medical significance (including status epilepticus, new / worsening of seizure types and withdrawal seizures) during exposure to anti-epileptic drugs, including rufinamide, in patients with LGS; incidence of hypersensitivity reactions during the exposure to anti-epileptic drugs, including rufinamide; common AEs identified with anti-epileptic drugs, as they may be related to this specific population; including sedation, neurological AEs, suicidal-related events, events associated with blood dyscrasias, and the potential increased risk of infections.

Secondary Outcome Measures :
  1. Long term use of rufinamide, and other anti-epileptic drugs [ Time Frame: At least three years ]
    Evaluation, within the constraints of this population, of the impact on maturation anddevelopment that anti-epileptic drugs, including rufinamide, has on the LGS population; seizure control in LGS patients, including those taking rufinamide and other anti-epileptic drugs; assessment of healthcare resource utilisation.

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


  • 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


  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01991041

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Sponsors and Collaborators
Eisai Limited

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eisai Limited Identifier: NCT01991041     History of Changes
Other Study ID Numbers: E2080-E044-401
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Eisai Inc. ( Eisai Limited ):
Lennox-Gastaut Syndrome

Additional relevant MeSH terms:
Lennox Gastaut Syndrome
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn