PhotoThera trial fails to reach significance

USA-based PhotoThera's NEST-2 trial of its transcranial laser therapy for acute ischemic stroke within 24 hours of stroke onset, did not meet  statistical significance, according to data presented at the American  Heart Association's International Stroke Conference in San Diego,  California.

The trial was a double-blind, sham-controlled study in 660 patients  who were 40-90 years of age with moderate-to-severe strokes and had not  received tissue plasminogen activator. TLT achieved a favorable outcome  in 36.3% of patients compared to only 30.9% of those in the control  group (p=0.094).

However, a post-hoc analysis of 434 patients who suffered  moderate-to-moderately-severe strokes showed a favorable outcome in  51.6% of those in the TLT group compared to 41.9% of subjects on placebo  (p=0.044). The firm says this statistically-significant result supports  a follow-on Phase III trial, NEST-3.