New drug to treat stroke complications tested in US for the first time as part of an international trial

A Roanoke, Va. woman is the first U. S. participant in an international, multi center trial of a new drug that shows promise in treating complications from a stroke.

The drug, clazosentan, is given in a continuous IV drip and was developed to treat patients with subarachnoid hemorrhage (bleeding between the membrane covering of the brain and the brain itself) caused by a burst aneurysm, which comprises six to eight percent of all strokes in the U.S. and are the most fatal.

It’s hoped that the drug can prevent cerebral vasospasm, a potentially deadly complication of stroke characterized by an unexplained narrowing of the brain’s arteries. Neurosurgeons call vasospasm the ‘black beast’ since it can kill or disable patients who were on the road to recovery after stroke surgery.

“Based on pre-clinical data in experimental models of subarachnoid hemorrhage and based on preliminary trials in Germany, we’re hopeful that this drug will be a major step to prevent vasospasm,” said Dr. Neal Kassell, professor of neurosurgery at the University of Virginia Health System and chairman of the Steering Committee in the trial of clazosentan. “It is the most encouraging drug we’ve seen to date.” The drug is manufactured by the Swiss company, Actelion Ltd., which is enrolling 400 patients in 65 medical centers worldwide. Study results are expected in the first half of 2006.

The first U. S. patient to participate in the trial of clazosentan is Norma Freday, 67, a mother of four and a desk clerk at the Airport Day’s Inn in Roanoke County. Freday was getting ready to go to work on May 30, Memorial Day, when she suddenly experienced a blinding headache. Freday quickly called 911 and an ambulance arrived in minutes.

“That quick action probably saved my life,” Freday says doctors told her.

Freday was flown that day from Roanoke to the UVa Medical Center because she was suffering from a subarachnoid hemorrhage caused by an aneurysm. At UVa, she underwent a special coiling procedure to fix the aneurysm and prevent the aneurysm from bleeding again. Freday’s children gave consent for her to participate in the clazosentan trial and she was home from the hospital, with no neurological problems, two weeks after first coming to UVa. Doctors say her prognosis is excellent.

Clazosentan is known as an endothelin A receptor antagonist. It acts by blocking the action of a peptide called endothelin, responsible for constricting the blood vessels.