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.
Like Sabril, Vigadrone carries a Boxed Warning regarding the risk of permanent vision loss and is only available to healthcare professionals and patients under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
Nuplazid, a non-dopaminergic, selective serotonin inverse agonist, targets 5-HT2A receptors that are thought to be involved in Parkinson's disease psychosis.
By testing type, detection rates were 32.6% for the epilepsy-related gene panel, 44.8% for the clinical WES gene panel, and 17.3% for WES.
This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.
The 5-year cumulative incidence of ICDs was 46.1% in 306 patients without ICDs at baseline (DA ever-users, 51.5%; DA never users, 12.4%).
"This virus is part of a group commonly known as the California serogroup of viruses," first author, John Lednicky, PhD. "These viruses are known to cause encephalitis in several species, including humans."
"If we are able to identify patients who are at risk for POCD, we can provide early treatment and encourage them to better understand the dysfunction," Hayashi said in a statement.
Individuals were better able to estimate the energy density of fat vs carbohydrate and fat + carbohydrate foods. This effect correlated with functional connectivity between the fusiform gyrus and ventromedial prefrontal cortex (visual and valuation areas).
The film is a new formulation of the dopamine agonist apomorphine, intended for rapid conversion from the OFF to the ON state; it has been studied to treat motor OFF episodes up to 5 times a day.
The researchers found that dexmedetomidine reduced the etomidate-induced sustained increase in α5 γ-aminobutyric acid type A receptor cell-surface expression (etomidate: 146.4 ± 51.6%; etomidate + dexmedetomidine: 118.4 ± 39.1% of control).
The independent data monitoring committee (IDMC) concluded that the 2 trials (AMARANTH and DAYBREAK-ALZ) investigating the treatment in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints of change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale.
Researchers compared cognition in 82 individuals with 50 or more years of type 1 diabetes (Medalists), 31 age-matched individuals with type 2 diabetes, and 30 age-matched control subjects without diabetes.
After those who developed dementia within 3 years after baseline were excluded and after adjustment for health behaviors, physical and psychiatric comorbidities, and sociodemographic factors, the estimated odds ratio for incident dementia was 0.71 for those with intellectual activities at baseline.
The sNDA included data from Study 311 (N=180), an ongoing, open-label, multicenter trial with an extension phase that evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa oral suspension as adjunctive therapy in children (4 to 11 years) with inadequately controlled POS or PGTC seizures.
Over a median follow-up of 12 years from symptom onset, long-term prognosis was favorable, with a resolution or improvement of the symptoms in more than half of the patients, with none developing VM, MD, or cerebellar dysfunction.
This investigational lentiviral-based gene therapy is currently being studied in the Phase 2/3 Starbeam Study, a 2-year study assessing the safety and efficacy of Lenti-D in boys ≤17 years old with CALD.
Janssen said in a statement that they are informing study participants (N>600), trial investigators, health authorities, ethics committees and institutional review boards about the situation.
The Agency has received reports of serious neural tube birth defects involving the brain, spine, and spinal cord in babies born to women who received dolutegravir for HIV treatment.
The researchers found that the mean Alzheimer's disease assessment scale-cognitive subscale score had increased to 25.2 and 23.8 in the exercise arm and usual care group, respectively, by 12 months (adjusted between-group difference, −1.4), indicating greater cognitive impairment in the exercise group
"The addition of cannabidiol at a dose of 10mg or 20mg per kilogram per day to a conventional antiepileptic regimen resulted in greater reductions in the frequency of drop seizures than placebo," the authors write.
Specifically, larger brain volume was associated with high intake of vegetables, fruit, whole grains, nuts, dairy, and fish, and low intake of sugar-containing beverages.
In this retrospective study, nursing home patients with dementia who had a hip fracture had improved survival if they underwent surgical repair compared to non-surgical management.
The FDA's decision was based on data from the Phase 3 PARADIGMS study (N=215) which evaluated the safety and efficacy of oral fingolimod vs interferon beta-1a injection in pediatric patients aged 10 to <18 years with relapsing MS.
The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.