Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

Acute Ischemic Stroke Clinical Trial

— NEST-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120301
• Other study ID #: NTS-INT08-009
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: November 14, 2013
• Start date: September 2010

Study information

• Verified date: October 2012
• Source: PhotoThera, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Federal Office for Safety in Health CareCanada: Health CanadaFinland: National Supervisory Authority for Welfare and HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: German Institute of Medical Documentation and InformationPeru: Instituto Nacional de SaludSweden: Medical Products AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: Swissmedic
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of acute ischemic stroke

2. Subject is not a candidate for treatment with neurothrombectomy

3. Initiation of the TLT procedure begins between 4.5 and 24 hours

4. Baseline NIHSS score range: 7-17

5. Full functional independence just prior to the present stroke episode

6. Negative pregnancy test in females of childbearing potential

7. Subject Informed Consent obtained prior to enrollment into this study

Exclusion Criteria:

1. Evidence of an intracranial, subdural, or subarachnoid hemorrhage

2. Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes

3. Seizure at stroke onset or within the 7 days prior to stroke onset

4. Sustained blood glucose >300 or <60 mg/dl

5. Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)

6. Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg)

7. A presumed and/or confirmed septic embolus

8. 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.

9. Head implant of any kind

10. Significant skin condition of the scalp (eg. psoriasis)

11. Use of any intravenous or intra-arterial thrombolytic medication

12. Use of any diagnostic or therapeutic interventional neurovascular procedure

13. Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Device:
• NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Locations

Country	Name	City	State
Austria	AKH Linz	Linz
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital - Walter C Mackenzie Health Science Center	Edmonton	Alberta
Canada	Trillium Health Centre	Mississauga	Ontario
Finland	Helsinki University Central Hospital	Helsinki
France	CHRU Lille-Hôpital Salengro	Lille
Germany	Neurologische Universitätsklinik Aachen	Aachen
Germany	Neurologische Klinik Bad Neustadt	Bad Neustadt
Germany	Charité Campus Berlin Mitte (CCM)	Berlin
Germany	Evangelisches Krankenhaus Bielefeld	Bielefeld
Germany	Heinrich-Heine-University of Düsseldorf	Düsseldorf
Germany	Neurologische Universitätsklinik Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Johann Wolfgang Goethe-University	Frankfurt am Main
Germany	Klinikum Frankfurt-Hochst	Frankfurt-Main
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinik und Poliklinik für Neurologie Leipzig	Leipzig
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Technische Universität München	München
Germany	Universitätsklinikum Münster	Münster
Germany	Kreisklinikum Siegen GmbH	Siegen
Germany	HSK, Dr. Horst Schmidt Klinik GmbH	Wiesbaden
Peru	Hospital Nacional Dos de Mayo	Lima
Spain	Complejo Hospitalario Universitario Albacete	Albacete
Spain	University Hospital Vall D'Hebron	Barcelona
Spain	Hospital Universitari Dr Josep Trueta	Girona
Sweden	Sahlgrenska University Hospital	Goteborg
Sweden	Sjukhuset i Lidköping	Lidköping
Sweden	Kärnsjukhuset Skövde	Skövde
Switzerland	Universitätsspital Basel	Basel
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	University Hospital Zürich	Zürich
United States	Mission Hospital/Mission Neurology Services	Asheville	North Carolina
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina Healthcare	Chapel Hill	North Carolina
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	Gwinnett Medical Center	Duluth	Georgia
United States	Scripps Encinitas Hospital	Encinitas	California
United States	INOVA Hospital	Falls Church	Virginia
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Guilford Neuro/The Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	The Methodist Hospital	Houston	Texas
United States	Saint Lukes Hospital	Kansas City	Missouri
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Stanford Stroke Center	Palo Alto	California
United States	Oregon Health Sciences University	Portland	Oregon
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Minneapolis Clinic of Neurology	Robbinsdale	Minnesota
United States	Harborview Medical Center	Seattle	Washington
United States	University of Washington St. Louis	St. Louis	Missouri
United States	Winchester Medical Center	Winchester	Virginia
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
PhotoThera, Inc

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Finland,  France,  Germany,  Peru,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability assessed using the dichotomous modified Rankin Scale (mRS)		Day 90	No
Primary	Adverse event differences between transcranial laser therapy and sham		Day 90	Yes
Secondary	Distribution of scores across the ordinal mRS		Day 90	No
Secondary	Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)		Day 90	No