A phase III trial of transcranial laser therapy has been discontinued after an interim analysis found no effect of laser therapy on patients' disability after ischaemic stroke. The transcranial laser device used in the trial was purported to provide energy to hypoxic mitochondria via near-infrared radiation, thereby limiting apoptosis. As soon as the results of the futility analysis were made available, venture capital groups liquidated the device manufacter, which seriously hindered the responsible termination of the trial and the reporting of results.
References
Hacke, W. et al. Transcranial laser therapy in acute stroke treatment: results of Neurothera Effectiveness and Safety Trial 3, a phase III clinical end point device trial. Stroke 10.1161/STROKEAHA.114.005795
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Transcranial laser therapy for stroke fails futility analysis. Nat Rev Neurol 10, 611 (2014). https://doi.org/10.1038/nrneurol.2014.200
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DOI: https://doi.org/10.1038/nrneurol.2014.200