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

This study has been completed.
Sponsor:
Information provided by:
PhotoThera, Inc
ClinicalTrials.gov Identifier:
NCT00419705
First received: January 5, 2007
Last updated: June 7, 2011
Last verified: June 2011

January 5, 2007
June 7, 2011
December 2006
July 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Disability scale (mRS)score at 90 days; safety of the treatment procedure
Complete list of historical versions of study NCT00419705 on ClinicalTrials.gov Archive Site
Functional neurological scale(NIHSS)over time [ Time Frame: at baseline, Day 5, 30, 60 and 90 ] [ Designated as safety issue: No ]
Functional neurological scale(NIHSS)over time
Not Provided
Not Provided
 
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
  • Experimental: Transcranial Laser Therapy
    Intervention: Device: NeuroThera® Laser System
  • Sham Comparator: Sham control procedure
    Intervention: Device: NeuroThera® Laser System
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. Epub 2009 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
July 2008
July 2008   (final data collection date for primary outcome measure)

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)
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Peru,   Sweden
 
NCT00419705
NTS-INT06-007
Yes
Jackson Streeter, MD, PhotoThera, Inc
PhotoThera, Inc
Not Provided
Study Chair: Justin Zivin, MD, PhD University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
PhotoThera, Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP