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

Lennox-Gastaut Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991041
• Other study ID #: E2080-E044-401
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: May 3, 2016
• Start date: June 2008
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lennox-Gastaut Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety during the use of rufinamide and other anti-epileptic drugs	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.	At least three years	Yes
Secondary	Long term use of rufinamide, and other anti-epileptic drugs	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.	At least three years	No