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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01991041
First received: November 18, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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
Lennox-Gastaut Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety during the use of rufinamide and other anti-epileptic drugs [ Time Frame: At least three years ] [ Designated as safety issue: Yes ]
    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:
  • Long term use of rufinamide, and other anti-epileptic drugs [ Time Frame: At least three years ] [ Designated as safety issue: No ]
    Evaluation, within the constraints of this population, of the impact on maturation and development 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.


Estimated Enrollment: 225
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rufinamide
Anti-Epileptic Drugs
Includes those used off label as part of local clinical practice

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01991041     History of Changes
Other Study ID Numbers: E2080-E044-401
Study First Received: November 18, 2013
Last Updated: November 18, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Eisai Inc.:
Lennox-Gastaut Syndrome

Additional relevant MeSH terms:
Syndrome
Intellectual Disability
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Disease
Epilepsy
Epilepsy, Generalized
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014