Transcranial Laser Therapy in Acute Stroke Treatment: Results of Neurothera Effectiveness and Safety Trial 3, a Phase III Clinical End Point Device Trial [Major Clinical Trial]

Conclusions—
Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset.

Clinical Trial Registration—
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01120301.

Source: Stroke - October 27, 2014 Category: Neurology Authors: Hacke, W., Schellinger, P. D., Albers, G. W., Bornstein, N. M., Dahlof, B. L., Fulton, R., Kasner, S. E., Shuaib, A., Richieri, S. P., Dilly, S. G., Zivin, J., Lees, K. R., for the NEST 3 Committees and Investigators, Broderick, Ivanova, Johnston, Norrvin Tags: Acute Cerebral Infarction Major Clinical Trial Source Type: research