Tag: Neurology Newsletter

Lennox-Gastaut syndrome and tuberous sclerosis complex :: Updates

Medicina

GW Clinical Trial Programs in Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex

 

In addition to the Dravet syndrome trials, GW is conducting the largest global pivotal clinical trial program to date in Lennox-Gastaut syndrome, another rare and severe form of epilepsy. The first Phase 3 trial is a placebo-controlled trial of Epidiolex (at a dose of 20 mg/kg) over a 14 week treatment period and has randomized 171 patients. This trial is expected to report top-line results in the second quarter of 2016. The second placebo-controlled trial has randomized a total of 225 patients and is expected to report top-line results mid-2016. The primary measure of efficacy in these two trials will be the comparison between Epidiolex and placebo in the percentage change in number of monthly drop seizures during the 14-week treatment period compared with the 4-week baseline observation period. ( Fonte: Neurologia.net www.neurologia.net ) 

–Neurologia

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Epidiolex for the treatment of Dravet Syndrome, a rare and severe form of epilepsy in children

Medicina

GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex ( Cannabidiol or CBD ) for the treatment of Dravet syndrome.

In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01). Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration ( FDA ) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the <>U.S. ( Fonte: Neurologia.net www.neurologia.net )

 

Medicina Newsletter

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