Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery

This study is a phase II (n= 200), prospective, double-blind, randomized, sham-controlled, multicenter, safety study of intravenous (IV) rt-PA alone versus IV rt-PA plus TLT (Transcranial Laser Therapy) at approximately 10 investigational sites (United States only). The primary endpoint for this safety study is occurrence of symptomatic intracranial hemorrhages at 36 - 48 hours after stroke symptom onset.

Symptomatic hemorrhage will be defined as deterioration of more than 4 points on the NIHSS lasting at least 72 hours accompanied by intracranial hemorrhage in the distribution of the neurological deficit as identified by neuroimaging scans. All follow up neuroimaging scans will be reviewed centrally by an independent reviewer for the presence or absence of hemorrhage on the 36-48 hour scan.

The secondary endpoints for this study are as follows:

• Hemorrhagic transformation without clinical consequences (asymptomatic) within 36-48 hours. All follow-up neuroimaging scans will be reviewed centrally by an independent reviewer for the presence or absence of hemorrhage on the 36-48 hour scan.
• Mortality
• The modified Rankin Scale (mRS) score dichotomized as 0-1 versus an mRS score of 2-6 at 90 days or the last rating in patients that develop intracerebral hemorrhages
• Frequency of SAEs and AEs This study is a phase II (N = 200), prospective, double-blind, randomized, sham controlled, multicenter, safety study of intravenous (IV) tissue plasminogen activator (rt-PA) versus IV rt-PA plus transcranial laser therapy (TLT) at approximately 10 investigational sites.

The study population will be randomized into two arms. One group will receive a sham TLT procedure (Sham Control Group or SCG) and the second group will receive an active TLT procedure (TLTG).

The randomization ratio of SCG and TLTG will be 1:1 and will be stratified in order to ensure balanced subject distribution between the treatment and sham-controlled groups for the following factors:

• Stroke severity as measured by National Institute of Health Stroke Scale (NIHSS) at baseline (stratified as 7-9, 10-13, 14-17)
• Study Site There are 6 visits in the study. The purpose of the Visit 1 will be to determine and confirm the eligibility of patients for participation in the StELLAR Study and document baseline information about the subject and their stroke event. This will include all of the following standard of care tests and procedures: a non contrast head CT scan performed prior to rt-PA administration, vital signs, height , weight ,physical exam, finger stick or blood glucose, serum or urine pregnancy test (if women of childbearing potential). In addition, the following data will be obtained: prestroke mRS, NIHSS, presumed location of stroke and vascular territory, start and stop date and time of the IV rt-PA treatment and dose given, date and time of stroke onset, date and time of arrival to the hospital, demographic data (date of birth, gender, ethnicity),sociodemographic data (education, marital status, social support prior to stroke),medical and surgical history (specific cardiovascular, neurological, endocrine, and other standard questions asked), method of contraception use (for women of child bearing potential), prior (three days prior to Screening) and current concomitant medication use, smoking history, adverse events from the time of obtaining informed consent. To be eligible for the study, the administration of rt-PA should follow the guidelines outlined by the National Institutes of Neurologic Disorders. Patients meeting the inclusion/exclusion criteria will be enrolled into the study after written informed consent is obtained by the patient or their legally authorized representative.