PhotoThera, Inc. completed an initial evaluation of the NeuroThera® Laser System (NTS) in the treatment of Subjects diagnosed with acute ischemic stroke within 24 hours of onset.  The study was entitled NeuroThera Efficacy and Safety Trial-1(NEST-1).

NEST-1 evaluated the safety and preliminary effectiveness of the NeuroThera Laser System (NTS) in improving 90-day outcomes in ischemic stroke patients treated within 24 hours of stroke onset.  The NTS is an investigational device that seeks to improve neurological outcome via non-invasive delivery of near-infrared (NIR) energy transcranially into the brain.

NEST-1 was a prospective, intention-to-treat, multicenter, international, double-blind trial involving 120 ischemic stroke patients randomized in a 2:1 ratio, with 79 patients in the active treatment group and 41 in the sham (placebo) control group. The Study included patients with baseline stroke severity measured by National Institutes of Health Stroke Scale (NIHSS) scores of 7 to 22.

Significantly more patients (70%) in the active treatment group had successful outcomes than did controls (51%), as measured prospectively on the binary NIHSS (P<0.05). The median time to treatment was 18 hours for the active group and 17 hours for the control group.  There were no statistically significant differences between the treatment and control groups with respect to Serious Adverse Events, and there were no adverse outcomes attributed to the therapeutic procedure.

The results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1) were published in the June 2007 issue of the journal Stroke (Stroke. 2007;38(6):1843-9).

NEST-2

The NeuroThera Effectiveness and Safety Trial 2 (NEST-2) [NTS-INT06-007] is a pivotal study to demonstrate the safety and effectiveness of the NeuroThera® Laser System (NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. This study is a prospective, double blind, randomized, sham-controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects at 51 centers in the US and 7 international centers.  The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.  In addition, Subjects will need to be between 40-90 years of age and include those who will meet all the inclusion criteria and will have none of the exclusion criteria. 

Effectiveness - Subjects will be followed for 90 days post-stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

Safety - The safety endpoints include the cumulative investigational device-related adverse event-free survival through 90 days follow-up, the cumulative procedure-related adverse event-free survival through 90 days follow-up, the number and percent of cumulative unanticipated investigational device-related, and  cumulative unanticipated procedure-related adverse events through 90 days follow-up after treatment with the NTS, and the safety of NTS in the delivery of infrared energy to the intended site based on adverse events though 90 days follow-up.