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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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