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
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Device: NeuroThera® Laser System
Phase 3

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

Further study details as provided by PhotoThera, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Functional neurological scale(NIHSS)over time [ Time Frame: at baseline, Day 5, 30, 60 and 90 ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: December 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Laser Therapy Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Sham Comparator: Sham control procedure Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419705

  Show 58 Study Locations
Sponsors and Collaborators
PhotoThera, Inc
Investigators
Study Chair: Justin Zivin, MD, PhD University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
  More Information

Publications:
Responsible Party: Jackson Streeter, MD, PhotoThera, Inc
ClinicalTrials.gov Identifier: NCT00419705     History of Changes
Other Study ID Numbers: NTS-INT06-007
Study First Received: January 5, 2007
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by PhotoThera, Inc:
acute stroke
infrared laser therapy
clinical trial
safety
effectiveness

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014