DIACOMIT® is the only antiepileptic drug to have clinically shown its efficacy in Dravet syndrome patients in two double blind randomized placebo controlled trials named STICLO France and STICLO Italy, conducted according the same protocol. The Italian study was performed after the French one and provided comparable results. STICLO France was published in one of the most renowned medical review: “The Lancet”
The objective of these pivotal studies was to confirm the effectiveness of DIACOMIT® in Dravet syndrome patients with pharmacoresistant seizures in spite of clobazam and valproate treatments.
The main efficacy criterion was the number of responders (patients with at least a 50% reduction of the number of seizures).
The two STICLO studies were performed according to the same protocol. Both of them were multicentric, double blind, placebo-controlled trials.
Included children were aged between 3 and 18 years. They had been clinically diagnosed as Dravet syndrome patients. All of them had had at least 4 tonic-clonic or clonic seizures during Month 1, while receiving clobazam and valproate.
At the end of Month 1, patients were randomised and then received 50mg/kg/day of Stiripentol or a placebo in addition to valproate and clobazam. All of them were followed during a 2 months period.
In STICLO France, 41 patients were analysed; 21 of them had received Stiripentol and 20 the placebo.
In STICLO Italy, 23 patients were analysed; 12 of them had received Stiripentol and 11 the placebo.
Results of the clinical trials:
In STICLO France, 71% of the DIACOMIT® patients were responders versus 5% in the placebo group.
In STICLO Italy, comparable results were observed with a responders’ rate of 67% for DIACOMIT® versus 9 % in the placebo group.
Furthermore in STICLO France, 9 patients were seizure-free in the DIACOMIT® group versus none in the placebo group. In STICLO Italy, 3 patients were seizure-free in the DIACOMIT® group, versus none in the placebo group.
Should you wish to get more information regarding DIACOMIT® pivotal studies viii, we invite you to read the product scientific discussion from the European Public Assessment Report.
For references, please access “About DIACOMIT” through the Bibliography part located in Resources tab.