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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhotoThera, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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