Ischemic StrokePhase 3NCT00419705
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
A Phase 3 study testing NeuroThera® Laser System in people with Ischemic Stroke, run by PhotoThera, Inc at 58 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- NeuroThera® Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 58 sitesin 4 countries
- Study dates
- Dec 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute Ischemic Stroke within 24 hours
- Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
- NIHSS ≥7 - ≤22
Who cannot join
- >24hours from symptom onset to time of treatment
- Evidence of intracranial, subdural, or subarachnoid hemorrhage
- Clinical presentation of intracranial hemorrhage
- Pre stroke ≥3 mRS
- The presence of a brainstem or cerebellar stroke
- Transient Ischemic Attack (TIA)
Show all 14Show fewer
- Seizure at stroke onset
- Blood glucose >400 or <60
- Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
- Septic embolus
- CNS tumor (except asymptomatic meningioma)
- Dermatologic condition of the scalp (e.g. Psoriasis)
- Thrombolytic therapy
- Head implant (e.g. Clipped aneurysm, Hakim valve)
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
United States51 sites
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
Alta Bates Summit Medical Center
Berkeley, California, 94705
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
UNC Health Care
Chapel Hill, North Carolina, 27514
Roper Hospital
Charleston, South Carolina, 29401
Charleston Area Medical Center (CAMC) General Hospital
Charleston, West Virginia, 25301
Erlanger Health System
Chattanooga, Tennessee, 37403
Intensive Care Unit, Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University Hospital
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Dekalb Medical Center
Decatur, Georgia, 30033
Dekalb Neurology Associates LLC
Decatur, Georgia, 30033
North Broward Medical Center
Deerfield Beach, Florida, 33064
Duke University Medical Center
Durham, North Carolina, 27710
Scripps Encinitas Hospital
Encinitas, California, 92024
Swedish Medical Center
Englewood, Colorado, 80113
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Parkview Hospital
Fort Wayne, Indiana, 46805
Benefis Healthcare East Campus
Great Falls, Montana, 59405
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
The Stroke Center at Hartford Hospital
Hartford, Connecticut, 06102
The Queen's Medical Center
Honolulu, Hawaii, 92822
The Methodist Hospital
Houston, Texas, 77030
St. Luke's Hospital
Kansas City, Missouri, 64111
Grossmont Hospital
La Mesa, California, 91942
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
UCLA Medical Center
Los Angeles, California, 90095
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53795
Loyola University Chicago
Maywood, Illinois, 60153
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901
Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, 08060
Naples Community Hospital
Naples, Florida, 34101
Munroe Regional Medical Center
Ocala, Florida, 34474
Tri City Medical Center
Oceanside, California, 92056
Stanford Hospital and Clinics
Palo Alto, California, 94305
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19140
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
Providence Portland Hospital
Portland, Oregon, 97213
Oregon Health & Science University - Oregon Stroke Center
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
The Valley Hospital
Ridgewood, New Jersey, 07450
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
Sharp Healthcare
San Diego, California, 92123
Saint Louis University
St Louis, Missouri, 63110
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598
Winchester Medical Center
Winchester, Virginia, 22601
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
University Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Germany4 sites
Neurologische Klinik des Universitatsklinikum Erlangen
Erlangen
Neurologische Klinik des Universitatsklinikum Heidelberg
Heidelberg
Klinik und Poliklinik fur Neurologic Leipzig
Leipzig
Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
Münster
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Sjukhuset i Lidkoping
Lidköping
About this 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
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- NeuroThera® Laser System
- Keywords
- acute stroke, infrared laser therapy, clinical trial, safety, effectiveness
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroThera® Laser SystemDevice
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Laser Therapy | Experimental | Not described Receives: Device: NeuroThera® Laser System |
| Sham control procedure | Sham comparator | Not described Receives: Device: NeuroThera® Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability scale (mRS)score at 90 days; safety of the treatment procedure
Measured: at baseline, day 5, 30, 60 and 90 post treatment
Secondary outcomes (1)
Functional neurological scale(NIHSS)over time
Measured: at baseline, Day 5, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotoThera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Justin Zivin, MD, PhD, Study chair, University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419705
- Sponsor's protocol ID
- NTS-INT06-007
- Status last verified
- Jun 2011
- First submitted
- 5 Jan 2007
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.
PubMed 19233936
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00419705
- Acronym / sponsor ID
- NTS-INT06-007
- Conditions
- Ischemic Stroke
- Keywords
- acute stroke, infrared laser therapy, clinical trial, safety, effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- PhotoThera, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Laser Therapy | Experimental | Device: NeuroThera® Laser System |
| Sham control procedure | Sham comparator | Device: NeuroThera® Laser System |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Acute Ischemic Stroke within 24 hours
- Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
- NIHSS ≥7 - ≤22
Key exclusion criteria (14 listed)
- >24hours from symptom onset to time of treatment
- Evidence of intracranial, subdural, or subarachnoid hemorrhage
- Clinical presentation of intracranial hemorrhage
- Pre stroke ≥3 mRS
- The presence of a brainstem or cerebellar stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroThera® Laser SystemTranscranial delivery of laser therapy or sham (no laser therapy) to the scalp | Device | Sham control procedure, Transcranial Laser Therapy |
Primary outcome
Disability scale (mRS)score at 90 days; safety of the treatment procedure
Time frame: at baseline, day 5, 30, 60 and 90 post treatment
1 secondary outcome
Functional neurological scale(NIHSS)over time
Time frame: at baseline, Day 5, 30, 60 and 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
- Results publication: PubMed 19233936Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Zivin, MD, PhD study chair
University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
58 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NeuroThera® Laser System in people with Ischemic Stroke, run by PhotoThera, Inc at 58 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Germany, Sweden, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability scale (mRS)score at 90 days; safety of the treatment procedure (time frame: at baseline, day 5, 30, 60 and 90 post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.