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PhotoThera, Inc. is a medical device company whose platform technology seeks to employ penetrating near-infrared laser energy to treat a broad range of diseases and health conditions. The company is initially focused on the treatment of ischemic stroke and is engaged in a clinical study to investigate the effect of its Transcranial Laser Therapy (TLT) when used within 24 hours of the onset of stroke symptoms.
| Clinical Application |
Study |
Subjects |
Study Type |
Status |
| Ischemic Stroke |
NeuroThera Effectiveness and Safety Trial-1 (NEST-1) |
120 |
Placebo-controlled, Double Blind, Randomized 2:1 |
Complete |
| Ischemic Stroke |
NeuroThera Effectiveness and Safety Trial-2 (NEST-2) |
660 |
Placebo-controlled, Double Blind, Randomized 1:1 |
Complete |
| Ischemic Stroke |
NeuroThera Efficacy and Safety Trial-3 (NEST-3) |
1,000 |
Placebo-controlled, Double Blind, Randomized 1:1 |
Enrolling |
Previous Clinical Trials
NEST-1
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.
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] was 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 was a prospective, double blind, randomized, sham-controlled, parallel group, multi-center study that included enrollment of 660 Subjects at 51 centers in the US and 7 international centers. The initiation of NTS treatment was within 24 hours of stroke onset for each Subject. In addition, Subjects were between 40-90 years of age and included those who met all the inclusion criteria and none of the exclusion criteria.
The results of the NeuroThera Effectiveness and Safety Trial-2 (NEST-2) are available online in the Journal Stroke. (http://stroke.ahajournals.org/cgi/content/short/40/4/1359)
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