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Questions hover over French clinical trial

Researchers are still trying to find out why one volunteer died and five others were hospitalised during a phase I clinical trial in Rennes, France, in January.

Biotrial, a contract research organisation, was carrying out the trial on the drug BIA 10-2474, manufactured by the company Bial, as a potential treatment for anxiety, chronic pain and movement disorders. The trial was halted on 11 January when adverse effects were reported. On 21 January the trial’s protocol was released by France’s national agency for the safety of medicines, the ANSM, after it had been leaked to the newspaper Le Figaro.

On 22 January the UK’s Royal Statistical Society (RSS) said that the published protocol lacked “essential” details on the dosing regimen.

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