Friday, August 10, 2012

NeuroThera® Efficacy and Safety Trial – 3 (NEST-3): a double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study to assess the safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System for the treatment of acute ischemic stroke within 24 h of stroke onset

Rationale Transcranial laser therapy is undergoing clinical
trials in patients with acute ischemic stroke. The NeuroThera
® Efficacy and Safety Trial-1 was strongly positive for
90-day functional benefit with transcranial laser therapy,
and post hoc analyses of the subsequent NeuroThera® Efficacy
and Safety Trial-2 trial suggested a meaningful beneficial
effect in patients with moderate to moderately severe
ischemic stroke within 24 h of onset. These served as the
basis for the NeuroThera® Efficacy and Safety Trial-3 randomized
controlled trial.
Aim The purpose of this pivotal study was to demonstrate
safety and efficacy of transcranial laser therapy with the
NeuroThera® Laser System in the treatment of subjects diagnosed
with acute ischemic stroke.
Design NeuroThera® Efficacy and Safety Trial-1-3 is a
double-blind, randomized, sham-controlled, parallel group,
multicenter, pivotal study that will enroll 1000 subjects at up
to 50 sites. All subjects will receive standard medical management
based on the American Stroke Association and
European Stroke Organization Guidelines. In addition to
standard medical management, both groups will undergo
transcranial laser therapy procedure between 4·5 and 24 h of
stroke onset. The study population will be randomized into
two arms: the sham control group will receive a sham transcranial
laser therapy procedure and the transcranial laser
therapy group will receive an active transcranial laser
therapy procedure. The randomization ratio will be 1:1 and
will be stratified to ensure a balanced subject distribution
between study arms.
Study Outcomes The primary efficacy end point is disability
at 90 days (or the last rating), as assessed on the modified
Rankin Scale, dichotomized as a success (a score of 0–2) or a
failure (a score of 3 to 6).

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