MedTrace Logo

Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

NCT00419705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2011-06-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

NeuroThera® Laser System

Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Sponsors & Collaborators

  • PhotoThera, Inc

    lead INDUSTRY

Principal Investigators

  • Justin Zivin, MD, PhD · University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Germany
  • Peru
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00419705 on ClinicalTrials.gov