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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lennox-Gastaut Syndrome Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epilepsy Epileptic Syndromes Genetic Diseases, Inborn Lennox Gastaut Syndrome Nervous System Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Nov 25, 2013
Registry last updated: May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed