all trials & studies

Study Name: "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT) 

Principal Investigator: David J Gladstone, MD
Coordinating Center: University of Calgary, Canada
Research Plan: This phase II double blind RCT will enroll 110 patients from approximately 15 Canadian stroke centres. Acute ICH patients who can be treated within 6 hours of onset will undergo CT angiography using standard CT procedures. Those with a spot sign will be randomly assigned in a 1:1 ratio to a single injection of rFVIIa 80 μg/kg or placebo; patients without a spot sign will not be treated. The primary endpoint is ICH expansion within 24 hours.
Target Enrollment: 110
Number of Study Sites: 15
Start Date: May 1, 2011
Anticipated Stop Date: Aug. 1, 2016
Funding Source: Sunnybrook Health Sciences Centre
Contact Information: David J Gladstone, MD; 403-944-8287; ademchuk@ucalgary.ca 
NCT Number: NCT01359202

Study Name: Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage-III (CLEAR-IVH III)

Principal Investigator: Daniel Hanley, Issam Awad
Coordinating Center: The Johns Hopkins University
Research Plan: CLEAR-IVH III is a study of intraventricular tPA for clearance of intraventricular hemorrhage (IVH). Patients with intraventricular hemorrhage (IVH) who have undergone placement of an external ventricular drain (EVD) will be enrolled. Clot size must be stable for at least 6 hours and tPA must be administered within 48 hours of onset. Placebo or 1 mg of tPA is administered via every 8 hours for up to 96 hours (12 doses) or clearance of IVH. The primary endpoint is 6-month modified Rankin scale score. Secondary endpoints include multiple functional outcome assessment scales, mortality, duration of ventricular drainage, and interval to clot resolution.
Target Enrollment: 500
Number of Study Sites: 70
Start Date: Fall 2008
Anticipated Stop Date: 2015 Funding Source: NINDS
Contact Information: klane@jhmi.edu 
NCT Number: N/A


Study Name: A randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus 

Principal Investigator: Eric Rosenthal, MD and Mark Wainwright, MD, PhD
Research Plan: This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Elilepticus (SRSE)
Target Enrollment: 140
Number of Study Sites: 173 
Study Site Locations: US, Canada, Europe, Israel
Start Date: June 2015
Anticipated Stop Date: June 2017
Funding Source: Sage Therapeutics
Contact Information: Helen Colquhoun, MD; helen@sagerx.com
NCT Number: NCT02477618

Link to study overview: Mp4 file - The download feature has been enabled from Vimeo so you can download the MP4's directly from there. There are multiple options for download depending on the size and compression needed - you can download whatever works. Here is the link:  URL:https://vimeo.com/217764900; PW: DPCG2017