Man left brain dead after clinical trial dies in hospital
pharmafile | January 18, 2016 | News story | Research and Development, Sales and Marketing | Bial, Biotrial, clinical trial
A man left brain dead after a clinical trial in France has died in hospital and five remain in a serious condition, with four participants believed to be suffering from severe neurological problems.
The head of the hospital’s neurology department has said that imaging scans suggest three of the patients may have irreversible brain damage, the New York Times reported. French prosecutors are investigating the case.
Further details of the trial emerged over the weekend, as it was revealed that the 128-person study was male-only in the area of pain. Ninety participants were given the experimental oral drug, with the rest taking placebos. All the men were aged 28 to 49.
Early reports that the drug was a cannabinoid-based painkiller were denied by the French Health Ministry, and Health Minister Marisol Touraine later confirmed that the pill acted on the body’s endo-cannabinoid system.
The trial was being conducted by the private research laboratory Biotrial in Rennes on behalf of Portuguese pharmaceutical company Bial, which confirmed that the new molecule being tested was an FAAH enzyme inhibitor. The trial had been ongoing since June, with no serious adverse events reported before Thursday, but is now suspended.
Bial said the trial was being conducted in accordance with the guidelines of Good Clinical Practices and that it was committed to ensuring the wellbeing of the participants. The Porto-based company added it would “determine thoroughly and exhaustively the causes which are at the origin of this situation.”
Phase I clinical trials most often involve healthy patients only and are conducted to test the safety of the drug being tested. The amount of the substance given to patients is generally slowly increased over time in order to determine the highest tolerated dosage.
The Rennes University Hospital released a statement Saturday confirming that 10 additional trial participants exposed to the drug had undergone tests on Saturday and were found not to be suffering from clinical abnormalities.
Joel Levy
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