Find out more about clinical trials at Johns Hopkins.
Safety and Efficacy of Sustained Release Dalfampridine in TM
Primary Investigator: Michael Levy, MD, PhD
Dalfampridine, a sustained-release potassium channel blocker that has been shown to be effective in improving gait and other neurologic functions in multiple sclerosis, has the potential to improve gait and neurologic function in patients with transverse myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis. We are performing a clinical trial to test the efficacy of dalfampridine in patients with monophasic TM.
This is an investigator-initiated study. Patients are eligible for participation that have been diagnosed with a single TM episode, are age 18 to 70, and have gait impairment such that they are able to complete a 25 foot timed walk in at least 5 seconds and in no more than 60 seconds. Patients are ineligible for participation who are unable to walk, have been diagnosed with MS or experienced recurrent inflammatory disease of the spine, have a history of seizure, are pregnant, have a known allergy or prior use of dalfampridine or any other formulation of 4-aminopyridine, have a history of severe alcohol or drug abuse, severe depression, psychiatric illness, or any other uncontrolled medical conditions.
Johns Hopkins Transverse Myelitis Center in Baltimore, MD is the only site conducting this study, which requires visits to the site every 2 weeks over approximately a 6-month period to test walking speeds and other outcome measures. Please contact Maureen Mealy at hopkinsTMCenter@jhmi.edu if you are interested in learning more about the study.
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA
Principal Investigator: Michael Levy, MD, PhD
Study Sponsor: Alexion Pharmaceuticals
The primary objective of the study is to assess the efficacy and safety of eculizumab treatment as compared to placebo in relapsing NMO patients using a time to first relapse study design.
Neuromyelitis Optica is a rare, severe disabling autoimmune inflammatory disorder of the central nervous system (CNS) that predominately affects the optic nerves and spinal cord, and is often characterized by a relapsing course. Complement activation is a key element in the development of CNS lesions in NMO. Eculizumab is a complement inhibitor that blocks conversion of C5 to C5a and C5b thus blocking terminal complement activation. The mechanism of action of eculizumab as a complement inhibitor suggests that it may provide therapeutic benefit in the management of NMO by reducing NMO relapses and thus reducing disability. In a recently reported investigator initiated trial, eculizumab reduced the annualized relapse rate in highly relapsing NMO patient population from a median of 3 relapses per year to zero relapses per year (p<0.0001). This phase 3 registrational trial is intended to confirm the safety and efficacy of eculizumab in the treatment of relapsing NMO.
Patients 18 years or older with the diagnosis of NMO or NMO spectrum disorder who have had clinical evidence of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months (with at least 1 relapse in the 12 months prior to screening) may qualify. Patients must be NMO-IgG seropositive.
For more information, please contact Regina Brock-Simmons at firstname.lastname@example.org.
CNS Growth Factor Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects with Inflammatory Myelopathies
Principal Investigator: Daniel Becker, MD
Volunteers with transverse myelitis, or multiple sclerosis, or NMO needed
The research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with history of spinal cord inflammation as seen in TM, MS, and NMO. FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. The FES cycling in this study will be done through a device called the RT300-SL Cycle Ergometer (RT300).
If you need additional information about a specific clinical research project or if you think that you may be eligible, please call the ICSCI Clinical Research Coordinator at 443-923-9235. Please be prepared to leave a detailed message, including the protocol number of the clinical research you are interested in and your contact information so that we may respond with a confidential message for you. You may also visit our website: www.spinalcordrecovery.org.
Collaborative International Research in Clinical and Longitudinal Experience for Neuromyelitis Optica (NMO) Studies (CIRCLES)
Principal Investigator: Michael Levy, MD, PhD
Study Sponsor: The Guthy-Jackson Charitable Foundation
The purpose of this multi-center study is to create an open-access repository containing longitudinally collected data and samples from subjects with neuromyelitis optica (NMO) and those collected from control subjects. These materials are intended to be used in research to better understand NMO pathogenesis, clinical course, and impact of therapy. Results of these studies may identify the etiology and risk factors, biomarkers for disease progression, and treatment outcomes to guide development of novel therapies. Findings may also facilitate future research and clinical trials to investigate specific hypotheses related to NMO and to improve the lives of individuals suffering from NMO.
Samples and data will be collected and de-identified. Please contact Regina Brock-Simmons at email@example.com for more information. Data collection begins in April 2014.
Find out more about Guthy-Jackson and the repository at: http://www.guthyjacksonfoundation.org/repository/.
An open-label study of bevacizumab for the treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica and neuromyelitis optica spectrum disorder
Principal Investigator: Michael Levy, MD, PhD
NMO is a severe, demyelinating autoimmune disease of the central nervous system that preferentially affects the optic nerves and spinal cord. Although historically considered a subtype of multiple sclerosis (MS) with overlapping symptoms, NMO is distinct radiologically and prognostically, and has a pathophysiology unresponsive to typical MS treatments.
This is a phase 2 investigator-initiated interventional trial of bevacizumab to evaluate the tolerability/safety and preliminary efficacy of bevacizumab as add-on therapy for treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of bevacizumab is added to standard-of-care high dose steroids and an additional dose of bevacizumab is added to plasma exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.
Patients may be eligible who are between the ages of 18 and 70 who present with acute optic neuritis and/or transverse myelitis and have a known or suspected diagnosis of NMO or NMO spectrum disorder. Female participants must not be pregnant and must commit to not becoming pregnant in the next 6 months from time of consent.
For more information, please contact Maureen Mealy at hopkinsTMcenter@jhmi.edu.
Quantification of Retinal Nerve Fiber Layer (RNFL) thickness using Optical Coherence Tomography (OCT)
Principal Investigator: Peter A Calabresi, MD, Professor of Neurology
Protocol #: NA_00031163
We are seeking adults with neuromyelitis optica (age 18-65) to participate in a study using retinal optical coherence tomography (OCT). This research is being done to better understand visual disability by measuring the nerve fiber thickness in the eye. We hope that the scan of the nerve layer thickness in the eye will help us better understand damage caused over time in patients with neuromyelitis optica. Participants will have an eye scan to measure the thickness of the back of the eye (retinal structures) and be asked to read 3 vision charts with black and gray letters. The eye scan is a safe, non-invasive procedure. No eye drops will be administered and participants with glasses or contacts are welcome. The eye scan and vision charts can be completed in approximately 30 minutes. Interested participants should contact Maureen Mealy, BSN at 410-502-8672.
Johns Hopkins Neurology Biorepository
Principal Investigator: Carlos Pardo, MD.
The purpose of this study is to have an electronic database for patient information, as well as to collect blood, spinal fluid, and other samples from individuals being evaluated or treated for central nervous system diseases (multiple sclerosis, transverse myelitis, acute disseminated encephalomyelitis, neuromyelitis optica, HIV, or infections of the nervous system). We are also collecting information and samples from patients with other neurologic diseases such as migraine, neuropathy and sarcoidosis. Furthermore, volunteers can participate as healthy controls in order to support various research efforts.
We are collecting these samples and medical information so that they can be made available to research scientists who study these diseases. The goal of this research is to improve upon our ability to diagnose these conditions