NEW ORLEANS (Reuters Health) - The results of a small placebo-controlled dosing study suggest that desmoteplase, an investigational clot-busting drug derived from vampire bat saliva, safely restores blood supply to the brain when administered up to 9 hours after stroke onset.
Dr. Anthony Furlan of the Cleveland Clinic Foundation in Ohio said that the reperfusion rate in patients randomized to 125 micrograms/kilogram IV desmoteplase was 53.3%, compared with 37.5% in the placebo arm.
Dr. Furlan presented results of the Dose Escalation study of Desmoteplase in Acute Ischemic Stroke (DEDAS) at a late-breaking clinical trials session Friday at the American Stroke Association International Stroke Conference 2005.
A second desmoteplase dose -- 90 micrograms/kilogram -- was not superior to placebo (18.2% reperfusion rate). However this dose was effective in an earlier European study and Dr. Furlan said it will be investigated in a large, multinational study of desmoteplase that will begin enrollment in April.
“In terms of safety, there were no symptomatic intracerebral hemorrhages,” he said. An earlier study of desmoteplase reported one symptomatic intracerebral hemorrhage. “Combining both studies the hemorrhage rate was 2%, which is less than the 6% hemorrhage rate reported with tPA,” he said.
The study randomized 38 acute ischemic stroke patients within 3 to 9 hours of stroke onset. Dr. Furlan presented results of the intention-to-treat analysis of 37 patients. Entry criteria included a National Institutes of Health Stroke Score (NIHSS) of 4 to 20. Moreover, Dr. Furlan said this is the first clinical trial to use MRI perfusion/diffusion mismatch as an eligibility criteria -- patients were required to have at least a 20% PWI/DWI mismatch on MRI.
Eight patients were randomized to placebo, 14 to 90 microgram/kilogram or 15 to 125 micrograms/kilogram of desmoteplase. At 90 days, 9 patients in the high-dose arm had clinical improvement (60%) versus 2 in the placebo arm (25%) and 4 in the lower dose arm (28.6%), but Dr. Furlan said these results were not clinically significant “because the study was too small to demonstrate significance.”
The study was funded by Paion Pharmaceutical in Aachen, Germany. The phase III trial will be supported by Forest Pharmaceuticals of St. Louis.
MeSH Headings:Brain Ischemia: Clinical Trials: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Medicine: Investigative Techniques: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Cardiovascular Surgical Procedures: Surgical Procedures, Operative: Reperfusion: Drugs, Investigational: Epidemiologic Study Characteristics: Clinical Trials, Phase II: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Hypoxia-Ischemia, Brain: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.