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Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects with Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial

What is this study about?

 

This study is looking at how effective and safe eslicarbazepine acetate (also known as ESL) is in people 18 years of age or older with partial-onset (focal) seizures, when it is added to their current anti-seizure medication(s).

The trial will look at a number of outcomes of taking ESL as a first or later add-on therapy including: effectiveness, number of seizures, safety and tolerability, mood and behavior, and quality of life.

Seizures will be recorded by a paper and electronic diary as well as an investigational wearable seizure detection device. This device will be given to each participant to use during the study.

There will be two ways that people can participate in this study. Details on each arm/group of the study are below.

Who can participate?

Eligibility criteria include:

  • Age 18 years or older
  • Diagnosis of epilepsy with the one or more of the following seizure types:
    • simple partial-onset (focal) seizures with motor symptoms
    • complex partial-onset (focal) seizure with impaired awareness
    • partial-onset (focal) seizure that goes into a generalized seizure
  • Has had at least 3 focal (partial) seizures in the six months prior to starting the study
  • Has never taken ESL before
  • Participants will be divided into the two study arms or groups based on whether they are:
    • Taking a stable dose of levetiracetam or lamotrigine for at least one month before screening, with no history of adjunctive (add-on) treatment (In this case, they would participate in Arm 1 of the study); OR,
    • Taking a stable dose of 1 or 2 anti-seizure drugs (except oxcarbazepine) for at least one month before screening, and have had prior add-on treatment (in this case, they would participate in Arm 2 of the study.

How can I participate?

  • This study is 31 weeks long – participants will be treated for 30 weeks with ESL.
  • The first 1-to-2 weeks is a screening phase to see if a participant is eligible for the study. Participants will record their seizure activity in a self-completed daily seizure diary.
  • The participant would then enter the 2-week titration phase followed by a 24-week maintenance phase as a part of either Arm 1 or Arm 2. During titration, the participant would start taking ESL and the dose would be increased up in regular increments to the assigned dose for the maintenance phase. The participant’s tolerance for the medication will be monitored. 
  • During the study, there are up to 10 site visits (where you would visit your local study site) and up to 3 telephone visits (where you would talk over the phone with a study manager), to have your health checked. These visits will vary, but may include electrocardiograms (ECG or EKG) (test of heart rhythms), physical examination (including blood pressure and heart rate), blood tests, and nervous system assessments.  
  • Following the maintenance phase, you finish the study with a 4-week safety follow-up, and either a taper phase (where you will be weaned slowly off the study drug) or with the option to remain on the commercially-available drug*.

Are there risks?

  • People with Asian ancestry may carry a genetic marker (called allele HLA-B*1502), which may put them at increased risk of a serious reaction on the skin and mucus membranes (e.g., Stevens-Johnson Syndrome) to ESL. A blood test to confirm that a person does not have this marker or proof that this testing has been done in the past is required before a person can enter the study.
  • With all trial drugs and devices, there is the chance the treatment may not improve a person’s seizures.
  • The dosing plans and safety checks that are designed to protect participants are detailed in a protocol. The protocol was designed by researchers and doctors, and was reviewed by an Institutional Review Board (IRB).
  • If the participant is unable to tolerate treatment with ESL, the study team will help them to taper off the medication slowly where possible, unless abrupt discontinuation is necessary.

For more information, visit https://clinicalconnection.com/clinical-trials-from-other-databases/study-location-selection/431534.

*After completion of this study, the study drug is commercially available and may be covered by insurance providers, and Medicare and Medicaid. Subjects will need to confirm with their individual insurance provider if they are covered under the terms of their policy with their provider. Sunovion Pharmaceuticals Inc. offers a Patient Assistance Program to subjects who are eligible to get help paying for their prescription.