A Professional-Caliber Contract Research Organization with Top Academic Expertise

  • Clinical Coordination
  • Biostatistics & Data Management
  • Therapeutic Expertise
  • Clinical Coordinating Center (CCC)
  • Centralized CT Reading Center
  • Surgical Support Center
  • Investigator Selection & Qualification
  • Clinical Site Management
  • Safety & Pharmacovigilance
  • On-site and Remote QA Monitoring
  • Regulatory (IND, IDE, GCP)
  • Data Coordinating Center (DCC)
  • Clinical Data Management
  • Advanced Biostatistics
  • Adaptive Randomization
  • Electronic Data Capture (EDC)
  • Electronic Trial Master File (eTMF)
  • Clinical Trial Management System (CTMS)
  • Online Training & Certification
  • Hemorrhagic Stroke (ICH, IVH)
  • Ischemic Stroke, TIA
  • Global Ischemia
  • Traumatic Brain Injury (TBI)
  • Encephalitis
  • Functional & Cognitive Outcomes
  • Epilepsy
  • Neurosurgery

Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
Office:   (410) 614-6996
Fax: (410) 502-7869
24-Hr: (410) 736-1368

Our Latest Clinical Trials

  • All
  • Epilepsy
  • Stroke
  • Default
  • Title
  • Date
  • Random
  • CLEAR-III is an international 500-patient randomized clinical trial evaluating thrombolysis vs. medical management alone in the treatment of intraventricular hemorrhage. With 75 hospitals participating, enrollment is expected to complete in late 2014.
    • Stroke
  • MISTIE-III is a 500-patient, international multicenter clinical trial launched in 2013 to confirm the safety and long-term efficacy of thrombolysis in the treatment of intracerebral hemorrhage (ICH). The 5-year trial is funded by NINDS and launched in 2013. Up to 100 of the top stroke centers across the world are expected to participate.
    • Stroke
  • EQUIGEN is composed of two bioequivalency trials. The EQUIGEN Chronic Dose trial is comparing two disparate generics of lamotrigine. The EQUIGEN Single Dose trial is comparing brand lamotrigine with two disparate generics of lamotrigine for patients with epilepsy. The University of Cincinnati has contracted with the Johns Hopkins Brain Injury Outcomes team to serve as the Coordinating Center and the Kansas University Medical Center to serve as the Data Management Center for both trials. The enrolling centers are: University of Cincinnati: Michael Privitera, MD; Donna Schwieterman (513) 558-3975 University of Rochester: Michel Berg, MD; Diane Smith (585) 275-0404 University of Alabama at Birmingham: Jerzy Szaflarski, MD: Nancy Cohen (250) 934-7244 Brigham & Women’s Hospital (Boston): Barbara Dworetzky, MD; Nichelle Llewellyn (617) 732-5423 University of Pennsylvania: John Pollard, MD; Meryl Lozano (215) 662-7227 University of Iowa: A. LeBron Paige, MD; Jeri Sieren (319) 356-8744
    • Epilepsy
  • MISTIE-II was a phase-II clinical trial across 32 clinical sites evaluating efficacy and long-term outcomes of thrombolysis in intracerebral hemorrhage (ICH). Results were presented at the 2013 International Stroke Conference.
    • Stroke
  • ICES was the third tier in the MISTIE phase-II clinical trial. ICES evaluated minimally-invasive endoscopic removal of the intracerebral hematoma as a faster alternative to catheter-delivered intermittent thrombolytic therapy. The last patient completed in 2013. Publication of final results is forthcoming. Meanwhile, plans are underway for the next phase of thise program.
    • Stroke