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Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome
Date:7/22/2014

LOS ANGELES, July 22, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ Therapy for the treatment of neurological and neuropsychiatric disorders, today announced that enrollment has begun in a pediatric open label study of external trigeminal nerve stimulation (eTNS) as adjunctive therapy for the treatment of Lennox-Gastaut Syndrome (LGS).

The trial is being conducted at the Olive View-UCLA Medical Center in Sylmar, California, and led by Professor D. Alan Shewmon, M.D., Chief of Neurology at Olive View and Vice Chair of Neurology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA).  The U.S. National Institutes of Health (NIH) has provided grant funding to NeuroSigma to support this open label trial of eTNS in children with LGS, ages 8 to 18.  The children in this study will use the eTNS therapy each night at home while remaining on their antiepileptic medications.  An earlier Phase II clinical trial of eTNS therapy for the treatment of drug-resistant epilepsy (DRE) in adults found significant improvements in the frequency of seizures with 18 weeks of nightly eTNS therapy. Dr. Shewmon does not have an affiliation with NeuroSigma.

LGS is a catastrophic form of childhood epilepsy characterized by three key features: multiple types of seizures, particularly "tonic" (stiffening) and "atonic" (drop) seizures; impaired intellectual development; and specific abnormalities on the electroencephalogram (brain wave test). Seizures usually develop between 3 and 5 years of age.  LGS is often difficult to control with ordinary antiepileptic drug treatments.  The Epilepsy Foundation reports that LGS accounts for 2-5% of chi
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