Date: 2012-06-04
Type of information:
phase: 2b-3
Announcement: initiation
Company: D&A Pharma (France)
Product: Alcover® (sodium oxybate)
Action
mechanism:
Disease: Alcohol dependence
Therapeutic area: CNS diseases - Mental diseases
Country: Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Slovakia, Spain,Sweden,
Trial
details: This clinical study is a double-blind, randomized, placebo-controlled clinical trial. It will recruit patients with an alcohol addiction will be divided into five distinct groups with access to four different doses of the product and placebo. m against placebo over a period of three months, an administration phase of the product of 12 weeks followed by a week of observation.
Latest
news: D & A Pharma, a biopharmaceutical company leading the field of addiction, has announced the launch of a multicenter clinical phase 2b/3 to be held in eight European countries to confirm, on a large population of patients, the efficacy and safety of ALCOVER®, its treatment against alcohol dependence. The product tested in this study is a solid formulation (pellets) of sodium oxybate.
The study aims to determine the most effective dose and better tolerated while confirming widespread effectiveness of ALCOVER ® in the treatment of alcohol dependence.
