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Sponsored by: |
PhotoThera, Inc |
---|---|
Information provided by: | PhotoThera, Inc |
ClinicalTrials.gov Identifier: | NCT00419705 |
The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
Condition | Intervention | Phase |
---|---|---|
Ischemic Stroke |
Device: The NeuroThera® Laser System (NTS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset |
Estimated Enrollment: | 660 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Device: The NeuroThera® Laser System (NTS)
device including shams
|
2: Sham Comparator |
Device: The NeuroThera® Laser System (NTS)
device including shams
|
This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. 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.
Ages Eligible for Study: | 40 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Justin Zivin, MD, PhD | University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093 |
Responsible Party: | PhotoThera, Inc ( Jackson Streeter, MD ) |
Study ID Numbers: | NTS-INT06-007 |
Study First Received: | January 5, 2007 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00419705 |
Health Authority: | United States: Food and Drug Administration |
acute stroke infrared laser therapy clinical trial safety effectiveness |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |