Acute Ischemic StrokePhase 3NEST-3NCT01120301
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
A Phase 3 study testing NeuroThera® Laser System in people with Acute Ischemic Stroke, run by PhotoThera, Inc at 60 sites in 10 countries.
Trial summary
The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute 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
- 1,000 participants
- Where
- 60 sitesin 10 countries
- Study dates
- Sep 2010to Sep 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute ischemic stroke
- Subject is not a candidate for treatment with neurothrombectomy
- Initiation of the TLT procedure begins between 4.5 and 24 hours
- Baseline NIHSS score range: 7-17
- Full functional independence just prior to the present stroke episode
- Negative pregnancy test in females of childbearing potential
- Subject Informed Consent obtained prior to enrollment into this study
Who cannot join
- Evidence of an intracranial, subdural, or subarachnoid hemorrhage
- Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
- Seizure at stroke onset or within the 7 days prior to stroke onset
- Sustained blood glucose >300 or <60 mg/dl
- Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)
- Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg)
Show all 13Show fewer
- A presumed and/or confirmed septic embolus
- History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment.
- Head implant of any kind
- Significant skin condition of the scalp (eg. psoriasis)
- Use of any intravenous or intra-arterial thrombolytic medication
- Use of any diagnostic or therapeutic interventional neurovascular procedure
- Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
United States26 sites
Mission Hospital/Mission Neurology Services
Asheville, North Carolina, 28801
University of Alabama Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina Healthcare
Chapel Hill, North Carolina, 27514
Erlanger Health System
Chattanooga, Tennessee, 37403
Cleveland Clinic
Cleveland, Ohio, 44195
Gwinnett Medical Center
Duluth, Georgia, 30096
Scripps Encinitas Hospital
Encinitas, California, 92024
INOVA Hospital
Falls Church, Virginia, 22042
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Parkview Hospital
Fort Wayne, Indiana, 46805
Guilford Neuro/The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
The Methodist Hospital
Houston, Texas, 77030
Saint Lukes Hospital
Kansas City, Missouri, 64111
Gwinnett Medical Center
Lawrenceville, Georgia, 30045
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Munroe Regional Medical Center
Ocala, Florida, 34474
Stanford Stroke Center
Palo Alto, California, 94304
Oregon Health Sciences University
Portland, Oregon, 97239
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Minneapolis Clinic of Neurology
Robbinsdale, Minnesota, 55422
Harborview Medical Center
Seattle, Washington, 98104
University of Washington St. Louis
St Louis, Missouri, 63110
Winchester Medical Center
Winchester, Virginia, 22601
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Germany18 sites
Neurologische Universitätsklinik Aachen
Aachen, D-52074
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, D-97616
Charité Campus Berlin Mitte (CCM)
Berlin, D-10117
Evangelisches Krankenhaus Bielefeld
Bielefeld, D-33617
Heinrich-Heine-University of Düsseldorf
Düsseldorf, D-40225
Neurologische Universitätsklinik Erlangen
Erlangen, D-91054
Universitätsklinikum Essen
Essen, D-45122
Johann Wolfgang Goethe-University
Frankfurt am Main, D-60528
Klinikum Frankfurt-Hochst
Frankfurt am Main, D-65929
Universitätsklinikum Hamburg-Eppendorf
Hamburg, D-20246
Universitätsklinikum Heidelberg
Heidelberg, D-69120
Klinik und Poliklinik für Neurologie Leipzig
Leipzig, D-04103
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, D-67063
Johannes Wesling Klinikum Minden
Minden, D-32429
Technische Universität München
München, D-81675
Universitätsklinikum Münster
Münster, D-48149
Kreisklinikum Siegen GmbH
Siegen, D-57076
HSK, Dr. Horst Schmidt Klinik GmbH
Wiesbaden, D-65199
Canada3 sites
University of Alberta Hospital - Walter C Mackenzie Health Science Center
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Spain3 sites
Complejo Hospitalario Universitario Albacete
Albacete, ES-02006
University Hospital Vall D'Hebron
Barcelona, 08035
Hospital Universitari Dr Josep Trueta
Girona, ES-17007
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, SE-405 30
Sjukhuset i Lidköping
Lidköping, SE-531 85
Kärnsjukhuset Skövde
Skövde, SE-541 85
Switzerland3 sites
Universitätsspital Basel
Basel, CH-4031
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
University Hospital Zürich
Zurich, CH-8091
About this study
Official title: NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset
The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.
- Conditions
- Acute Ischemic Stroke
- Being tested
- NeuroThera® Laser System
- Keywords
- stroke
- 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 assessed using the dichotomous modified Rankin Scale (mRS)
Measured: Day 90
Adverse event differences between transcranial laser therapy and sham
Measured: Day 90
Secondary outcomes (2)
Distribution of scores across the ordinal mRS
Measured: Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
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 Acute 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhotoThera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Hacke, MD PhD, Study chair, Heidelberg UniversityJustin Zivin, MD PhD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120301
- Sponsor's protocol ID
- NTS-INT08-009
- Acronym
- NEST-3
- Status last verified
- Oct 2012
- First submitted
- 5 May 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.
PubMed 25293665
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset
- ClinicalTrials.gov ID
- NCT01120301
- Acronym / sponsor ID
- NEST-3 / NTS-INT08-009
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- PhotoThera, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- First posted
- 10 May 2010 (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 efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.
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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of acute ischemic stroke
- Subject is not a candidate for treatment with neurothrombectomy
- Initiation of the TLT procedure begins between 4.5 and 24 hours
- Baseline NIHSS score range: 7-17
- Full functional independence just prior to the present stroke episode
Key exclusion criteria (13 listed)
- Evidence of an intracranial, subdural, or subarachnoid hemorrhage
- Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
- Seizure at stroke onset or within the 7 days prior to stroke onset
- Sustained blood glucose >300 or <60 mg/dl
- Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)
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 assessed using the dichotomous modified Rankin Scale (mRS)
Time frame: Day 90
Adverse event differences between transcranial laser therapy and sham
Time frame: Day 90
2 secondary outcomes
Distribution of scores across the ordinal mRS
Time frame: Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Time frame: Day 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 15 Nov 2013.
- Derived from this study: PubMed 25293665Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.
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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.
Werner Hacke, MD PhD study chair
Heidelberg University
Justin Zivin, MD PhD study chair
University of California, San Diego
60 sites in 10 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 Acute Ischemic Stroke, run by PhotoThera, Inc at 60 sites in 10 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 7 inclusion and 13 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 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Germany, Canada, Spain, Sweden and 5 more countries. 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 assessed using the dichotomous modified Rankin Scale (mRS) (time frame: Day 90). The study lists 2 primary outcomes in all. 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 NCT01120301, 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 15 Nov 2013.