Forest Laboratories has become the latest pharmaceutical company to launch a clinical trial registry, where it says it has posted results from all paediatric and adolescent studies for its antidepressants, Lexapro (escitalopram) and Celexa (citalopram), as well as information regarding ongoing clinical studies for products under development.
Additional clinical trial information will be added to the registry as completed studies are summarised into the correct registry format, as new studies are initiated, and as ongoing studies are completed and summarised. The firm says that full data summaries for completed qualifying clinical studies will be posted to the registry by the end of December this year.
The move comes hot on the heels of similar registries launched by other pharmaceutical companies, including GlaxoSmithKline, and Eli Lilly, and Roche [[02/09/04a]], [[04/08/04b]], [[24/01/05a]]. The world’s major pharmaceutical industry trade associations from Europe, Japan and the USA, also recently pledged to include all Industry-sponsored clinical trials, regardless of outcome, on a global database [[07/01/05a]].
- Meanwhile, Forest says that it has started a Phase IIb/III study of its investigational clotbuster, desmoteplase, in the treatment of acute ischemic stroke, which it claims affects over 600,000 patients in the US each year.
The trial, dubbed DIAS2, will include more than 150 patients in a bid to confirm the results of earlier Phase II studies that demonstrated the product’s potential in the treatment of acute ischemic stroke patients up to nine hours after the onset of stroke symptoms – three times longer than the currently available treatment allows. Most stroke patients arrive at the hospital outside the accepted three hour treatment window, and the majority are not eligible for the currently available treatment. Forest expects that lengthening the treatment window could expand the number of patients who could benefit from treatment.