Last updated: 11/07/2018 10:21:46

Plan for Re-Evaluation of Sudden Unexplained Death in Epilepsy (SUDEP) Occurring in the Lamotrigine Clinical Development ProgramRESUDEP

GSK study ID
116318
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Plan for Re-Evaluation of Sudden Unexplained Death in Epilepsy (SUDEP) Occurring in the Lamotrigine Clinical Development Program
Trial description: This study will quantify the risk of SUDEP in previousley completed lamotrigine clinical trials sponsored by GlaxoSmithKline (GSK).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants classified as "Definite SUDEP" or "Probable SUDEP" using Annegers Classification.

Timeframe: 3-9 months

Secondary outcomes:

Number of participants classified as Definite SUDEP, SUDEP+ or Probable SUDEP/Probable SUDEP+ on New Unified Proposed Classification scale

Timeframe: 3-9 months

Number of participants classified as Definite SUDEP, SUDEP+, Probable SUDEP/Probable SUDEP+ or Possible SUDEP on New Unified Proposed Classification scale

Timeframe: 3-9 months

Number of participants classified as "Definite SUDEP", "Probable SUDEP", or "Possible SUDEP" using Annegers Classification.

Timeframe: 3-9 months

Interventions:
  • Drug: Placebo
  • Drug: Lamotrigine
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Tomson T, Hirsch LJ, Friedman D, Bester N, Hammer AE, Irizarry M, Ishihara L, Krishen A, Spaulding TC, Wamil AW, Leadbetter R. Sudden Unexpected Death in Epilepsy (SUDEP) in Lamotrigine Randomized Controlled Trials. Epilepsia.2013;54(1):135-140
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to February 2012
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    2 Months - 75 Year
    Accepts healthy volunteers
    none
    • Inclusion criteria vary from study to study, in general following were required:
    • Diagnosis of epilepsy
    • Varies from study to study depending on the target population. For example for study of subjects with partial seizures, - subject is excluded if he/she exhibits any primary generalized seizures (e.g., absence, myoclonic, primary generalized tonic-clonic seizures).
    • has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria vary from study to study, in general following were required:
    • Diagnosis of epilepsy
    • Documented history of seizzures
    • Concurrently receiving other AED's
    • Ability to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate, complete,written daily seizure diary for the entire duration of the study.
    • Understand and sign written informed consent, or will have a parent or a legally authorized representative who has done so, prior to the performance of any study assessments
    • If female, and of childbearing potential, be using an acceptable form of birth control.
    Exclusion criteria:
    • Varies from study to study depending on the target population. For example for study of subjects with partial seizures,
    • subject is excluded if he/she exhibits any primary generalized seizures (e.g., absence, myoclonic, primary generalized tonic-clonic seizures).
    • has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
    • abusing alcohol and/or other substance(s).
    • has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
    • planning surgery to control seizures during the study
    • has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-17-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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