LIEGE, Belgium, November 8, 2011 /PRNewswire/ --
PREMICE clinical trial proves Cefaly® medical device efficacy in migraine prevention and points out that Cefaly® has the best safety-efficacy ratio compared to other treatments.
On Monday 7th of November a press conference took place in Liege Science Park. Professor Jean Schoenen, principal investigator, neurologist and professor at Liege University (Belgium) presented the results of PREMICE (Prevention Migraine Cefaly) a multicenter randomized double-blind placebo controlled clinical trial for migraine prevention with the Cefaly® neurostimulator.
The clinical trial was conducted in 5 Belgian university hospitals on 67 patients. The results prove the efficacy of the Cefaly® compared to placebo for migraine prevention. At 3 months of treatment the 50% responder rate was significantly greater in the Cefaly® group (38,1%) than in the placebo group (12,1%). Seventy percents of patients declared they were satisfied or very satisfied with the Cefaly® treatment. The drug consumption reduction is very impressive in the Cefaly® group (-37%) compared to the placebo group (+0.5%). Cefaly® responder group drug consumption reduction was -75%!
Without noticeable side effects or contraindications, Cefaly® is very safe. Cefaly® has a similar efficacy than preventative drugs, but without side effects. Consequently, Cefaly® has the best safety-efficacy ratio of all migraine treatments.
Prof. Schoenen: "This clinical trial has been implemented according to the highest quality standard and it proves that Cefaly® is efficient for migraine prophylaxis. Efficacy is similar with the most efficient preventative drugs but with the great advantage of having no side effects."
Cefaly® is an innovative medical device protected by a series of patents. This is the first cranial external neurostimulation device on the market. Cefaly® neurostimulation is applied to the upper branch of the trigeminal nerve. A self-adhesive electrode is applied on the forehead and the device is placed on this electrode in the position of a pair of glasses. Very accurate pulses are transmitted through the electrode to the nerve endings of the trigeminal nerve.
STX-Med Company is a startup based in Liege (Belgium), which launched the Cefaly® technology project in 2005. The company STX-Med is ISO Medical. Cefaly® device has the medical CE-marked. It is available on the European market for 295 € and in Canada as well.
SOURCE STX-Med