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

Phase 3

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT00419705
• Lead Sponsor: PhotoThera, Inc

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-09
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability scale (mRS)score at 90 days; safety of the treatment procedure	at baseline, day 5, 30, 60 and 90 post treatment

Secondary Outcome Measures

Name	Time	Method
Functional neurological scale(NIHSS)over time	at baseline, Day 5, 30, 60 and 90

Trial Locations

Locations (58)

Sparks Regional Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Alta Bates Summit Medical Center; 🇺🇸 Berkeley, California, United States

Scripps Encinitas Hospital; 🇺🇸 Encinitas, California, United States

Grossmont Hospital; 🇺🇸 La Mesa, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Tri City Medical Center; 🇺🇸 Oceanside, California, United States

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States

Neurology Medical Group of Diablo Valley; 🇺🇸 Walnut Creek, California, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

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