The safety and efficacy of clobazam monotherapy in patients with new-onset focal or generalized seizures was investigated in a new Cochrane systematic review.

Researchers searched various databases to identify trials that compared clobazam monotherapy to placebo or another antiepileptic drug in patients with ?2 unprovoked seizures or a single acute symptomatic seizure requiring short-term continuous treatment. Retention time, defined as time on allocated treatment, was set as the primary outcome, while short- and long-term efficacy, tolerability, quality of life, and tolerance measures were considered secondary outcomes.

The researchers identified 3 studies that met the inclusion criteria (N=206), however none of the trials reported on the selected primary outcome. “Lack of detail regarding allocation concealment and a high risk of performance and detection bias in 2 studies prompted us to downgrade the quality of evidence (by using the GRADE approach) for some of our results due to risk of bias,” the authors noted.

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

Vagus nerve stimulation (VNS) therapy has been an option to treat pharmacoresistant seizures for 30?years. In this update, researchers review the clinical data that support the device’s efficacy in children, adolescents, and adults. They also review its side-effect profile, quality of life and cost benefits, and the impact the device has on sudden unexpected death in epilepsy (SUDEP). Researchers then discuss candidate selection and provide guidance on dosing and future models.

Vagus nerve stimulation therapy is an effective treatment for many seizure types and epilepsy syndromes with a predictable and benign side-effect profile that supports its role as the most commonly prescribed device to treat pharmacoresistant epilepsy.

Zogenix, Inc. reported positive top-line results from its second confirmatory Phase 3 study (Study 1504) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of children and young adults with Dravet syndrome. The study results, which are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, successfully met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), is superior to placebo when added to a stiripentol regimen.

In the maze of our brains, there are various pathways by which neural signals travel. These pathways can go awry in patients with neurological and psychiatric diseases and disorders, such as epilepsy, Parkinson’s, and obsessive-compulsive disorder. Researchers have developed new therapeutic strategies to more precisely target neural pathways involved in these conditions, but they often require surgery.

The latest findings from the laboratory of Mikhail Shapiro, assistant professor of chemical engineering at Caltech, are now showing how scientists and doctors might, in the future, selectively turn neural circuits on and off–without the need for surgery. The new study, featured in the July 9 online edition of Nature Biomedical Engineering, demonstrates how the method–which involves a trio of therapies: ultrasound waves, gene therapy, and synthetic drugs–can be used to specifically alter memory formation in mice.

“By using sound waves and known genetic techniques, we can, for the first time, noninvasively control specific brain regions and cell types as well as the timing of when neurons are switched on or off,” says Shapiro, who is also a Schlinger Scholar and a Heritage Medical Research Institute Investigator. The work has implications for basic research in animals and for the future treatment of neurological and psychiatric conditions.

The researchers say they hope to continue testing in animals with models of diseases such as epilepsy. Many patients with epilepsy currently undergo surgery to cut out the regions of their brain where seizures are thought to be triggered. With the ATAC method, specific brain areas could, in theory, be switched off temporarily without surgery.

The main purpose of this study is to see whether brivaracetam has a faster onset time and greater effect than levetiracetam in subjects with photosensitive seizures. Part 1 of the study will compare the effects of levetiracetam 1500 mg with the effects of brivaracetam 100 mg. Part 2, will compare the effects of levetiracetam 1500 mg with the effects of brivaracetam 100 mg or will compare the effects of levetiracetam 500mg with the effects of brivaracetam 25 mg.

Estimated study start date: June 1, 2018
Estimated study completion date: February 2019

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria

• Patients between 18 and 65 years of age
• Male or female
• PPR at minimum at 60,50,40,30,25,20,18 or 16 Hz as upper threshold
• Drug naïve or at most with up to 4 AEDs, not being LEV or BRV

Exclusion Criteria

• Current treatment with more than 4 AEDs
• LEV or BRV as current treatment or used in the previous month.
• History of severe side-effects or psychological side-effects with LEV or BRV use
• Being pregnant or insufficiently protected against pregnancy (see also ref 31) or lactating Female
• Serious internal medical disease (renal/hepatic/cardiovascular disease) as deemed by the on-site physician (WER)
• History of psychiatric disease that has been a reason for acute hospitalisation for their condition of depression, schizophrenia, mania, delirium or aggressive behaviour
• History of status epilepticus
• History of significant ethanol or illicit drug use