National Stroke Association is committed to furthering scientific advances for stroke. A clinical trial is currently recruiting patients at sites within the U.S.
H. Lundbeck A/S is conducting two phase III trials of desmoteplase, a new thrombolytic for treating acute ischemic stroke (AIS). Desmoteplase is intended to be administered within three to nine hours after the onset of ischemic stroke symptoms.
The trial is ongoing in more than 200 sites worldwide, including more than 72 sites across the U.S. The 2 trials will enroll a total of 880 patients (worldwide) between the ages of 18 and 85.
Desmoteplase is being studied in two clinical trials named DIAS-3 and DIAS-4 (Desmoteplase in Acute Ischemic Stroke). In the program conducted so far, the safety of desmoteplase was investigated in the Dose Escalation of Desmoteplase for Acute Ischaemic Stroke (DEDAS) and Desmoteplase in Acute Ischaemic Stroke (DIAS) Phase II trials and the DIAS-2 Phase III trial. DIAS-3 and DIAS-4 are aimed at examining the efficacy of the treatment in patients with ischemic stroke with an occlusion or severe stenosis in the affected cerebral blood vessel.
In 2009, DIAS-3 and DIAS-4 were started, and the results of these trials will determine whether desmoteplase will gain marketing authorization as a safe and effective treatment for patients with AIS. Patient inclusion in DIAS-3 is mainly focused in Asia and Europe; while in DIAS-4 most sites are located in the U.S., with six more sites in process of being activated. Patient safety is continuously monitored.
The important milestone of enrolling more than 50 percent of the required number of patients in DIAS-3 was passed at the end of 2011.
For study locations and inclusion/exclusion criteria, visit the trial registration page (NCT00856661) at www.clinicaltrials.gov.
To get more information on this trial, please email LundbeckClinicalTrials@lundbeck.com.