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

June 7, 2011 updated by: PhotoThera, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany
        • Neurologische Klinik des Universitatsklinikum Erlangen
      • Heidelberg, Germany
        • Neurologische Klinik des Universitatsklinikum Heidelberg
      • Leipzig, Germany
        • Klinik und Poliklinik fur Neurologic Leipzig
      • Munster, Germany
        • Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
  • Peru
      • Lima, Peru
        • Hospital Nacional "Dos de Mayo"
  • Sweden
      • Goteborg, Sweden
        • Sahlgrenska University Hospital
      • Lidkoping, Sweden
        • Sjukhuset i Lidköping
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center
      • Encinitas, California, United States, 92024
        • Scripps Encinitas Hospital
      • La Mesa, California, United States, 91942
        • Grossmont Hospital
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Oceanside, California, United States, 92056
        • Tri City Medical Center
      • Palo Alto, California, United States, 94305
        • Stanford Hospital and Clinics
      • San Diego, California, United States, 92123
        • Sharp HealthCare
      • Walnut Creek, California, United States, 94598
        • Neurology Medical Group of Diablo Valley
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • The Stroke Center at Hartford Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • North Broward Medical Center
      • Ft. Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Melbourne, Florida, United States, 32901
        • Health First Holmes Regional Medical Center
      • Naples, Florida, United States, 34101
        • Naples Community Hospital
      • Ocala, Florida, United States, 34474
        • Munroe Regional Medical Center
      • Port Charlotte, Florida, United States, 33952
        • Fawcett Memorial Hospital
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Decatur, Georgia, United States, 30033
        • Dekalb Neurology Associates LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 92822
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Intensive Care Unit, Northwestern Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Chicago
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University Massachusetts Memorial Medical Center
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • St. Louis, Missouri, United States, 63110
        • Saint Louis University
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare East Campus
    • New Jersey
      • Mount Holly, New Jersey, United States, 08060
        • Virtua Memorial Hospital of Burlington County
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Health Care
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27401
        • The Moses H. Cone Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The University Hospital
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Hospital
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University - Oregon Stroke Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Hospital of University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
      • Virginia Beach, Virginia, United States, 23454
        • Sentara Virginia Beach General Hospital
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Charleston Area Medical Center (CAMC) General Hospital
    • Wisconsin
      • Madison,, Wisconsin, United States, 53795
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of Acute Ischemic Stroke within 24 hours
  2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
  3. NIHSS ≥7 - ≤22

Exclusion Criteria:

  1. >24hours from symptom onset to time of treatment
  2. Evidence of intracranial, subdural, or subarachnoid hemorrhage
  3. Clinical presentation of intracranial hemorrhage
  4. Pre stroke ≥3 mRS
  5. The presence of a brainstem or cerebellar stroke
  6. Transient Ischemic Attack (TIA)
  7. Seizure at stroke onset
  8. Blood glucose >400 or <60
  9. Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
  10. Septic embolus
  11. CNS tumor (except asymptomatic meningioma)
  12. Dermatologic condition of the scalp (e.g. Psoriasis)
  13. Thrombolytic therapy
  14. Head implant (e.g. Clipped aneurysm, Hakim valve)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Laser Therapy
Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Sham Comparator: Sham control procedure
Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disability scale (mRS)score at 90 days; safety of the treatment procedure
Time Frame: at baseline, day 5, 30, 60 and 90 post treatment
at baseline, day 5, 30, 60 and 90 post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional neurological scale(NIHSS)over time
Time Frame: at baseline, Day 5, 30, 60 and 90
at baseline, Day 5, 30, 60 and 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhotoThera, Inc

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTS-INT06-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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