Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419705
• Other study ID #: NTS-INT06-007
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: June 7, 2011
• Start date: December 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2011
• Source: PhotoThera, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 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

• Ischemia
• 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
Germany	Neurologische Klinik des Universitatsklinikum Erlangen	Erlangen
Germany	Neurologische Klinik des Universitatsklinikum Heidelberg	Heidelberg
Germany	Klinik und Poliklinik fur Neurologic Leipzig	Leipzig
Germany	Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat	Munster
Peru	Hospital Nacional "Dos de Mayo"	Lima
Sweden	Sahlgrenska University Hospital	Goteborg
Sweden	Sjukhuset i Lidkoping	Lidkoping
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Alta Bates Summit Medical Center	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	UNC Health Care	Chapel Hill	North Carolina
United States	Charleston Area Medical Center (CAMC) General Hospital	Charleston	West Virginia
United States	Roper Hospital	Charleston	South Carolina
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Intensive Care Unit, Northwestern Memorial Hospital	Chicago	Illinois
United States	The University Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Dekalb Medical Center	Decatur	Georgia
United States	Dekalb Neurology Associates LLC	Decatur	Georgia
United States	North Broward Medical Center	Deerfield Beach	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Scripps Encinitas Hospital	Encinitas	California
United States	Swedish Medical Center	Englewood	Colorado
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Holy Cross Hospital	Ft. Lauderdale	Florida
United States	Benefis Healthcare East Campus	Great Falls	Montana
United States	The Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	The Stroke Center at Hartford Hospital	Hartford	Connecticut
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	The Methodist Hospital	Houston	Texas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Grossmont Hospital	La Mesa	California
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	UCLA Medical Center	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics	Madison,	Wisconsin
United States	Loyola University Chicago	Maywood	Illinois
United States	Health First Holmes Regional Medical Center	Melbourne	Florida
United States	Virtua Memorial Hospital of Burlington County	Mount Holly	New Jersey
United States	Naples Community Hospital	Naples	Florida
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Tri City Medical Center	Oceanside	California
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Fawcett Memorial Hospital	Port Charlotte	Florida
United States	Oregon Health & Science University - Oregon Stroke Center	Portland	Oregon
United States	Providence Portland Hospital	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	The Valley Hospital	Ridgewood	New Jersey
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Sharp Healthcare	San Diego	California
United States	Saint Louis University	St. Louis	Missouri
United States	Sentara Virginia Beach General Hospital	Virginia Beach	Virginia
United States	Neurology Medical Group of Diablo Valley	Walnut Creek	California
United States	Winchester Medical Center	Winchester	Virginia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	University Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
PhotoThera, Inc

Countries where clinical trial is conducted

United States,  Germany,  Peru,  Sweden, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability scale (mRS)score at 90 days; safety of the treatment procedure		at baseline, day 5, 30, 60 and 90 post treatment	Yes
Secondary	Functional neurological scale(NIHSS)over time		at baseline, Day 5, 30, 60 and 90	No