Clinical trial NCT00419705: Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: acute stroke
infrared laser therapy
clinical trial
safety
effectiveness
Lead sponsor: PhotoThera, Inc
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 660
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Disability scale (mRS)score at 90 days; safety of the treatment procedure
timeFrame: at baseline, day 5, 30, 60 and 90 post treatment
Secondary outcomes:
measure: Functional neurological scale(NIHSS)over time
timeFrame: at baseline, Day 5, 30, 60 and 90
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Encinitas
country: United States
facility: Scripps Encinitas Hospital
state: California
city: La Mesa
country: United States
facility: Grossmont Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Oceanside
country: United States
facility: Tri City Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Walnut Creek
country: United States
facility: Neurology Medical Group of Diablo Valley
state: California
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Hartford
country: United States
facility: The Stroke Center at Hartford Hospital
state: Connecticut
city: Deerfield Beach
country: United States
facility: North Broward Medical Center
state: Florida
city: Ft. Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Decatur
country: United States
facility: Dekalb Medical Center
state: Georgia
city: Decatur
country: United States
facility: Dekalb Neurology Associates LLC
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Intensive Care Unit, Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University Massachusetts Memorial Medical Center
state: Massachusetts
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Great Falls
country: United States
facility: Benefis Healthcare East Campus
state: Montana
city: Mount Holly
country: United States
facility: Virtua Memorial Hospital of Burlington County
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Asheville
country: United States
facility: Mission Hospitals - Memorial Campus
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Health Care
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: The Moses H. Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The University Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Portland Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University - Oregon Stroke Center
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Virginia Beach General Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC) General Hospital
state: West Virginia
city: Madison,
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Erlangen
country: Germany
facility: Neurologische Klinik des Universitatsklinikum Erlangen
city: Heidelberg
country: Germany
facility: Neurologische Klinik des Universitatsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Klinik und Poliklinik fur Neurologic Leipzig
city: Munster
country: Germany
facility: Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
city: Lima
country: Peru
facility: Hospital Nacional "Dos de Mayo"
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lidkoping
country: Sweden
facility: Sjukhuset i Lidkoping
Study officials:
affiliation: University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
name: Justin Zivin, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.