Patient in French Clinical Trial Dies, Others Recovering
A patient injured in a clinical trial in France has died, according to the University Hospital of Rennes, where he was being treated.
The man, who had been reported braindead after participating in the study of an oral FAAH enzyme inhibitor for the potential use in mood and motor disorders, died last week. Five other participants in the study conducted by the CRO Biotrial also were treated at the hospital. They reportedly are improving, with two sent to neurology departments closer to home, two remaining in Rennes and a fifth released with no further symptoms.
The clinical trial had been studying Portuguese drugmaker Bial’s candidate to test its impact on healthy patients. The six patients — males between 28 and 49 — experienced neurological side effects, leading the French Health Ministry to call for an investigation, which is ongoing.
With 90 clinical trial participants exposed to the compound, the university hospital has provided neurological exams and MRIs and is continuing to offer them to concerned subjects. No brain damage has been discovered in any other patients.