ing the first month of treatment and was sustained during the entire treatment period. Results from secondary efficacy endpoints reinforced the overall effectiveness observed with Epidiolex. Epidiolex was generally well tolerated in this study. The most common adverse events (occurring in greater than 10% of Epidiolex-treated patients) were: somnolence, diarrhoea, decreased appetite, fatigue, pyrexia, vomiting, lethargy, upper respiratory tract infection and convulsion. Of those patients on Epidiolex that reported an adverse event, 84% reported it to be mild or moderate. Ten patients on Epidiolex experienced a serious adverse event vs. three patients on placebo. Eight patients on Epidiolex discontinued treatment due to adverse events compared with one patient on placebo [11].
15/03/2016 10:11:25
Dec 15: Results of open label trial published in the Lancet neurology. In this single arm, open label study (214 enrolled patients) the median monthly reduction in frequency of motor seizures was 36.5% from a median baseline of 30.0 events per month. Serious adverse events were reported in 30% of patients [10].
06/01/2016 09:34:58
May 15: GW Pharmaceuticals begins a PIII trial of Epidiolex for LGS. GW anticipates that top-line data from the 14-week, 150-patient trial, which closely follows the start of two late-stage studies assessing the drug in another rare childhood epilepsy called Dravet syndrome, will be available early next year [9].
12/05/2015 12:29:33
Apr 15: In an open-label study reported at the American Academy of Neurology meeting, cannabidiol reduced the number of seizures by an average of 54% among patients with severe, treatment-resistant epilepsy [8].
24/04/2015 12:03:44
Mar 15: GW Pharmaceuticals has begun a PIII trial, the second part of a two-part randomised, double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy study of the drug in children treated with other anti-epileptic drugs. Part one - the pharmacokinetic and dose-finding elements of the trial - completed earlier this year. Part two is a 14-week comparison of Epidiolex versus placebo in a total of 100 patients to assess the drug’s safety and efficacy as an adjunctive anti-epileptic treatment. Top-line data should be available by the end of 2015, with a view of submitting a New Drug Application in the US mid-2016 [7].
24/04/2015 12:03:35
Oct 14: The PII/III trial is a two-part randomised double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy study of single and multiple doses of epidiolex to treat Dravet Syndrome in children in addition to other anti-epileptic drugs. Part one will comprise the pharmacokinetic and dose-finding elements in 30 pts over 3 weeks and part two will be a placebo-controlled safety and efficacy eva luation over 3 months in 80 pts. All pts who complete the study will be eligible to enter an open label extension study.[6]
24/04/2015 12:03:28
Oct 14: PII/III trial commenced in the US. An additional Phase 3 trial is anticipated in the 1st quarter of 2015 in parallel with part two of the first PII/III trial [6].
24/04/2015 12:03:03
Feb 15: NCT02224703 A PIII Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. Starts Mar 15, due to complete Dec 15. NCT02224690 A PIII Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive |
