The Traditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial is a randomized controlled trial that will recruit 900 patients across approximately 45 sites within the United States. It will help inform patients and the broader healthcare community on whether patients would most benefit from early, possibly more risky aggressive therapy or if starting with a less aggressive (and, often, less risky) therapy, followed by a switch if breakthrough disease activity occurs, is warranted. In addition, this study will help identify if there is a specific patient population or short-term biomarker(s) that is strongly predictive of long-term disability that can result from MS. BIOS is serving as the coordinating center. Read More
VICTAS is a clinical trial to test the combination of Vitamin C, thiamine, and hydrocortisone for the treatment of sepsis. All enrolled patients will receive the standard intensive care for sepsis, and half of the patients will additionally receive vitamin C, thiamine, and hydrocortisone. These drugs will be given via an IV every six hours for a total of 96 hours. Data will be collected regarding the use of vasopressors (drugs that increase blood pressure), respiratory support (treatments to aid breathing), and the status of the patients at 30 days and up to one year after treatment. BIOS is serving as the clinical trial coordinating center. Read More
Placebo-Controlled Effectiveness in INPH Shunting (PENS) is a trial aiming to evaluate of CSF shunting in INPH patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity. The primary hypothesis of the PENS trial is that treatment of idiopathic normal pressure hydrocephalus (INPH) with an open shunt results in improved gait velocity. BIOS is serving as the coordinating center, centering around site startup, including IRB and contracting for local and international sites, training verification and regulatory document collection for study sites. The clinical coordinating center facilitates communication between the data coordinating center and lead clinical site and plans and runs the biweekly core team meetings. Read More
Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome.
The Type 2 Diabetes Prevention with Airway Pressure trial (DPAP) Trial is a prospective multicenter randomized trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. The trial, which is in its planning phase, will investigate whether treatment of obstructive sleep apnea with positive airway pressure therapy is associated with a decrease in the incidence of type 2 diabetes in people with prediabetes. BIOS serves as the data coordinating center. Read More
AVERT is a randomized multicenter clinical trial evaluating video-oculography (VOG), nystagmography, and audiometry in patients presenting to an emergency department with dizziness or vertigo. The study is designed to determine if these non-invasive tests of eye movement and hearing when combined with a structured treatment plan, resulting in a better diagnosis. BIOS serves as the clinical trial coordinating center and data management center. Read More
HU Prevent is a clinical study that aims to compare the drug hydroxyurea to a placebo in children with sickle cell disease. The goal of this clinical trial is to determine if hydroxyurea can prevent brain injury. Some of the most devastating complications of sickle cell disease, including stroke, silent stroke, and fast blood flow to the brain, can occur early in a child’s life. Through information gained from the HU Prevent Study, we hope to help prevent these common problems in children with sickle cell disease. BIOS is serving as the national coordinating center. Read More
The MISTIE trials were randomized, placebo-controlled, international clinical trials of minimally invasive surgery (MIS) plus alteplase in the treatment of intracerebral hemorrhage (ICH). Subjects were randomized 1:1 to minimally invasive surgery plus alteplase or standard of care with no surgical intervention. The MISTIE Trial was designed to determine the safety of using the combination of MIS and clot lysis with alteplase, while the primary outcomes of the phase 3 trial focused on functional outcomes, measured by the mRS score at 180 and 365 days, and mortality. BIOS served as the clinical coordinating center and data coordinating center for these projects. Dr. Hanley holds the IND for rt-PA use in the setting of ICH.
MTI:M3 (MISTIE III substudies)
MTI:M3 combines three MISTIE III DSMB-approved sub-investigations. These ancillary studies evaluated whether specific biomarkers can predict who will benefit the most from minimally invasive surgery. BIOS served as the coordinating center.
The CLEAR-IVH trial, completed in 2008, was a phase 2 feasibility and dose-finding trial conducted at 20 centers in the U.S., Canada, UK, and Germany. There were 3 phases: Safety, CLEAR A, and CLEAR B. The study enrolled 52 patients with a confirmed diagnosis of intraventricular hemorrhage (IVH) with third or fourth ventricle obstruction. Patients were given a thrombolytic, recombinant tissue plasminogen activator (tPA) via an extraventricular catheter (EVD) in one of three dosing regimens over a 3-day period. CLEAR III was a 500-patient phase 3 randomized clinical trial using a recombinant tissue plasminogen activator (Activase) to remove blood from the ventricles quickly. More than 70 major hospitals and academic institutions participated in this international clinical trial.
Following CLEAR III, we launched a clinical registry to help stroke researchers and scientists gain valuable information about the use of intraventricular thrombolytic therapy and techniques evaluated.
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH II)
ATACH II was a pragmatic, streamlined randomized design to evaluate the efficacy of intensive SBP reduction and its effect on outcomes measures in subjects with ICH. Patients were randomized 1:1 to either standard or intensive SBP management using intravenous nicardipine hydrochloride as the primary blood pressure control agent for 24 hours from randomization. This trial was terminated early following an interim analysis that found there was no significant outcome differences between groups. BIOS served as the independent oversight committee for protocol compliance and safety.
This prospective, open-label, non-randomized, comparative study was designed to compare the accuracy and safety of the HS-1000 device, a non-invasive intracranial pressure (ICP) monitor, to invasive ICP monitoring via an external ventricular drain. The HS-1000 measures ICP by assessing the acoustic properties of the patient’s head. BIOS served as the data management center and provided clinical coordinating center responsibilities of site start-up and site management.
Equivalence Among Antiepileptic Drug Generic and Brand Products in People with Epilepsy (EQUIGEN studies)
The objective of the EQUIGEN studies was to evaluate the bioequivalence of brand and disparate generic lamotrigine tablets in people with epilepsy receiving stable dose of lamotrigine (chronic dose study) and receiving stable dose of an anti-epileptic medication that is not lamotrigine (single dose study). This research was designed to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy.
Study of Motor Learning and Acute Recovery Time Course in Stroke (SMARTS)
SMARTS (SMARTS-1 and SMARTS-2) was a series of studies at Johns Hopkins exploring how the brain changes over the first year following a stroke. BIOS provided trial coordination for the pilot study, SMARTS-1. SMARTS used several non-invasive techniques, including MRI, transcranial magnetic stimulation, and measures of arm movement to learn more about how individuals recover from stroke. It is hoped that this information will help predict recovery and help researchers understand how changes in the brain relate to the performance of movement.