Clinical Trial: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR)

The VALOR study is investigating whether Lacosamide (Vimpat®)—when taken with current anti-epileptic medicine—helps decrease the number of seizures patients experience. This study enrolls children and adults who are at least 4 years or older, have epilepsy with primary generalized tonic-clonic seizures, had at least 2 seizures in the past 12 weeks, and are on a stable dose of anti-epileptic medicines. Patients have a 50% chance of receiving placebo; they have the opportunity to receive Lacosamide for another two years afterwards in an open-label extension study. The study is running in a total of 23 countries, including the United States.

Eligibility Criteria:

Ages Eligible for Study: 4 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalizedtonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
  • Subject has 3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
  • If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
  • Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Antiepileptic drugs (AEDs) OR 1 to 3 AEDs (with 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS)
  • Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

 

Exclusion Criteria:

  • History of partial onset seizures or EEG findings indicating partial onset seizures
  • Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
  • Lifetime history of suicide attempt, or suicidal ideation in past 6 months
  • Women of child bearing potential must practice contraception according to protocol requirements
  • Regular use of clozapine, monoamine oxidase (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
  • Use of Vigabatrin within the last 6 months

Clinical Trail: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

The BELLE study is investigating whether Brivaracetam (Briviact®) given intravenously (into the vein) is safe for children and what it does in the body. This study enrolls children who are between 1 month and 16 years of age who have epilepsy and are currently treated with at least one anti-epileptic medicine. All children will receive Brivaracetam in the study, which can take between 3 and 68 days, depending on the child’s condition. The study is running in a total of eight countries, including the US.

Eligibility Criteria:

Ages Eligible for Study: 1 Month to 16 years (child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement
  • Weight >= 3 kg (6.6 lbs)
  • Diagnosis of epilepsy
  • Acceptable candidate for venipuncture and intravenous (iv) infusion
  • Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening
  • No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening
  • For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods

Exclusion Criteria:

  • Subject has previously received iv Brivaracetam (BRV) in this study
  • Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg
  • Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period
  • Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods
  • Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period

Crowdsourced Algorithms Predict Epilepsy Seizures

Thanks to the crowdsourcing of more than 10,000 algorithms from around the world, epileptic seizure prediction is possible in a wider range of patients than previously thought, according to new research.

In 2016, researchers ran the Seizure Prediction Challenge on the online data science competition platform Kaggle.com. The contest focused on seizure prediction using long-term electrical brain activity recordings from humans obtained in 2013 from the world-first clinical trial of the implantable NeuroVista Seizure Advisory System.

Researchers rigorously evaluated the top algorithms and report their findings in Brain: A Journal of Neurology.

Levin Kuhlmann, from the Graeme Clarke Institute at the University of Melbourne and St. Vincent’s Hospital in Melbourne, says the contest was a huge success, with more than 646 participants, 478 teams, and more than 10,000 algorithms from around the world.

Compound from Spider Venom Reduces Seizure Susceptibility, Mortality in Dravet Syndrome Mice

A compound isolated from spider venom called Hm1a helps reduce seizure susceptibility and mortality in mice with Dravet syndrome, according to researchers.

Their study, “Selective NaV1.1 activation rescues Dravet syndrome mice from seizures and premature death,” was published in PNAS.

Dravet syndrome is resistant to several pharmaceutical therapies that are geared toward treatment of other types of epilepsy. This creates an urgent need to develop new therapeutic strategies to treat this genetic disease.

Most patients with Dravet syndrome have a mutation in the SCN1A gene which results in a deficiency in the sodium channel NaV1.1. In the brain, NaV1.1 is expressed on the surface of nerve cells and plays a critical role in nerve-nerve cell signaling.

Spider venom is a rich source of compounds that target ion channels, much like Nav1.1.

Hm1a is a peptide — short chains of amino acids, which are the building blocks of proteins — present in spider venom that selectively improves the functioning of Nav1.1.

Clinical Trail: Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children

The ASPIRE study is investigating whether Lacosamide (Vimpat®) given intravenously (into the vein) is safe for children and what it does in the body. This study enrolls children who are between 1 month and 16 years of age who have epilepsy, and for whom intravenous infusion is an option. All children will receive Lacosamide for a period that can last up to 45 days, but may be as short as one day, depending on the child’s condition. The study is running in a total of seven countries, including the US.

Eligibility Criteria:

Ages Eligible for Study: 4 Years to 16 years (child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Male or female from >=4 to <17 years of age
  • Subject has a diagnosis of epilepsy with partial-onset seizures or primary generalized tonic-clonic seizures
  • Subject meets 1 of the following criteria:
    • Open-label lacosmide (OLL) subject: Subject is currently receiving oral lacosmide (LCM) as adjunctive or monotherapy as participants in an open label long-term study (SP848, EP0034, or other pediatric study); OR,
    • Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
    • Initiating intravenous lacosamide (IIL) subject: Subject is not currently receiving LCM and will receive intravenous (iv) LCM as adjunctive treatment in EP0060. Initiation of LCM monotherapy is not permitted in IIL subjects.
  • Subject is an OLL or RxL subject and meets both of the following criteria:
    • Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND,
    • Subject has been administered (OLL) or prescribed (RxL) oral LCM at a dose of 2mg/kg/day to 12mg/kg/day (for subjects <50kg) or 100mg/day to 600mg/day (for subjects >=50kg). Open-label study drug LCM (OLL) or prescribed oral LCM dose (RxL) must be stable for at least 3 days prior to first LCM infusion; OR,
  • Subject is an ILL subject and is on a stable dosage regimen of at least 1 antiepileptic drug (AED). The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 2 weeks prior to Screening.
  • Subject is an acceptable candidate for venipuncture and iv infusion
  • Subject is, in the opinion of the investigator, able to comply with all study requirements. Subject (or parent[s] or legal representative) is willing to comply with all study requirements

 

Exclusion Criteria:

  • Subject has previously received intravenous (iv) lacosamide (LCM) in this study
  • Subject has any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject’s health or compromise the subject’s ability to participate in EP0060
  • Subject has clinically significant hypotension or bradycardia in the opinion of the investigator
  • Subject >=6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by positive responses (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening