The phase IIB study aims to recruit 225-250 patients in total from Sweden, UK, Germany and Poland. Successfully approving 29 patients to begin the trial process on the first day alone is significant, says Nordkild:
“4-5% of women of a fertile age suffer from PMDD today, and yet they’re mostly being offered no treatment, or SSRI anti-depressants, which produce their own negative side effects. Our trial product, Sepranolone, is a natural, endogenous compound that isn’t an anti-depressant or a hormone. It delivered 80% symptom relief In Phase IIA clinical trials, and we’re confident it can treat PMDD—and help millions of women take back control of their lives.”
Symptoms of PMDD, the severest form of PMS, include mood swings, rage, anxiety and depression, disrupting families, relationships and careers. The phase IIB study is a randomized, placebo-controlled, double-blind clinical study that will enrol 225-250 patients in Sweden, UK, Germany and Poland. The first four German trial clinics now running are in Berlin, Frankfurt, Schwerin and Essen (with Nurnberg soon to follow). In Poland, the clinical in Krakow has started (with Warsaw, Elblag and Katowice soon to follow) along with a site in Sweden-Stockholm. Three clinics in England will start soon-in London, Liverpool and Stoke on Trent.
If you want more information on the study go here.