This is why negative results are rarely published. We need a stroke association to follow up on all stroke research and report on them. But they won't, it is too much like work.
http://www.medpagetoday.com/Cardiology/Strokes/48074?
Details of the failed pivotal NEST 3 trial outline just how little impact transcranial laser therapy had on ischemic stroke.
The rate of good functional outcome at 90 days came out similar
with application of the near-infrared frequency laser soon after stroke
compared with a sham treatment (49.6% versus 49.3% modified Rankin
Scale 0 to 2), Werner Hacke, MD, PhD, of Ruprecht-Karl University of Heidelberg, Germany, and colleagues found.
The
adjusted odds ratio was 1.024 after inclusion of all 630 randomized
patients (95% confidence interval 0.705-1.488), the group reported in
the November issue of Stroke.
"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," they concluded.
The initial phase II results had looked promising, but the phase IIb trial, dubbed NEST-2, failed.
The NEST 3 trial was stopped in October 2012 after the interim analysis suggested futility.
MedPage Today reported dim prospects for release of the trial data
earlier this year, as all financial support for the trial was
immediately withdrawn and the company dissolved after the futility
determination.
"Proper termination of the trial was difficult but
was finally achieved through special efforts by former employees of
PhotoThera, the clinical research organization Parexel, and members of
the steering and the safety committees," Hacke's group explained.
NEST
3 had been intended to randomize 1,000 patients with acute ischemic
stroke not treated with thrombolytic therapy to either active or sham
transcranial laser treatment within 24 hours after stroke onset.
There
are near-infrared light therapy devices FDA approved for
musculoskeletal pain indications, although in these indications these
may simply act as a heat source.
The technology has also been investigated for use in traumatic brain injury, Alzheimer's disease, Parkinson's disease, and some other neurological conditions.
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