Clinical Studies & Trials

Investigator: Michael Levy, MD, PhD
Study Site: Johns Hopkins University, Baltimore, MD
Collaborator: Acorda Therapeutics

Study Details

The goal of this clinical trial is to test the efficacy of dalfampridine in patients diagnosed with Transverse Myelitis. Dalfampridine is a sustained-release potassium channel blocker that has been shown to be effective in improving gait and other neurologic functions in multiple sclerosis. Dalfampridine has the potential to improve gait and neurologic function in patients with transverse myelitis because of a similar pathogenic process with multiple sclerosis.

The clinical trial will focus on monophasic idiopathic Transverse Myelitis (TM) and will evaluate the efficacy of dalfampridine in primary neurologic outcome – 25-foot timed walk, and several secondary outcomes including valid behavioral and neurophysiological measures. To better understand the mechanisms underlying the proposed behavioral gains, the investigators will use Transcranial Magnetic Stimulation as the neurophysiologic measure to identify changes in corticomotor excitability in the spinal cord.

All study participants will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. At the conclusion of this first 10-week trial, subjects will be crossed over to the other therapy for another 8 weeks and 25-foot timed walking assessments will again be done every 2 weeks.

Eligible Participants

Patients (18-65 years) diagnosed with idiopathic transverse myelitis confirmed by MRI will be eligible to participate in this study.

Diagnosis of any other recurrent CNS disease including multiple sclerosis, recurrent myelitis, or neuromyelitis optica is an exclusion criteria for the study.

Other exclusion criteria include:

• History of seizure(s).
• Pregnancy or positive pregnancy test (mandatory test for all women aged 18-55 to be done at first screening visit).
• Known allergy to dalfampridine or any other formulation of 4-aminopyridine.
• Patients unable to walk.
• Patients with history of severe alcohol or drug abuse, severe psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
• Patients with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, claudication, uncontrolled epilepsy or others).

Contact Information

If you are interested in participating, please contact the Johns Hopkins University at the contact below.

Maureen Mealy, RN | Email: hopkinstmcenter@jhmi.edu

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446575

For more information, please visit the NIH ClinicalTrials.gov site here

Investigator: Benjamin Greenberg, MD, MHS
University of Texas Southwestern Medical Center, Dallas, TX

Study Details

This observational study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. The study is seeking to understand why some patients respond to medications, while others do not; and what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Eligible Participants

Patients previously diagnosed with Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis and healthy controls will be eligible to participate in this study.  Males and females six years and older, who are either able to consent for themselves or where the parent is able to give informed consent, and who are able to maintain scheduled visits to University of Texas Southwestern Medical Center will be recruited in this study. Patients will donate serum, plasma, DNA, RNA and white blood cells. There is no monetary compensation. There is no cost to you. You will not receive any personal health benefits as a result of your participation in this observational research study. We hope that the results will help us better identify new ways of diagnosing and treating these disorders. Your participation is voluntary.

Contact Information

If you are interested in participating, please contact the University of Texas Southwestern Medical Center at the contacts below.

Morgan C. McCreary, BS| 214-645-0561| Morgan.McCreary@utsouthwestern.edu
Samuel Hughes, BS| 214-645-7977| Samuel.Hughes@utsouthwestern.edu

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623076

Investigator: Eric Klawiter, MD
Massachusetts General Hospital, Harvard Medical School, Boston, MA

Study Details

This research is being conducted to study the effect of pregnancy on Neuromyelitis Optica (NMO). It commonly affects females of childbearing age. To date, women’s health issues in NMO have not been studied in detail. Determining the effect of pregnancy on the NMO disease course is of great importance in counseling patients on family planning. Information will also be gathered on the incidence of complications of pregnancy and the incidence of miscarriages.

Eligible Participants

The study is enrolling females age 18 or older with NMO. Participants do not need to have been pregnant in the past to participate. Participants can be NMO antibody positive or negative as long as they carry the diagnosis of NMO. Participation would involve completing a survey that will be administered over the phone and should take 10-20 minutes of your time. There is no monetary compensation. There is no cost to you. You will not receive any personal health benefits as a result of your participation in this research study. We hope that the results will help us better understand NMO, and might benefit patients with NMO in the future. Your participation is voluntary.

Contact Information

If you are interested in participating, please contact: Dr. Eric Klawiter at 617-726-7643. Please be prepared to leave a detailed message, including the name of the study and your contact information (so that you can receive a confidential message in response).

Investigator: Daniel Becker, MD
Hugo W. Moser Research Institute at Kennedy Krieger, Baltimore, MD

Study Details

This research is being conducted to evaluate change in function (spasticity, strength, and sensation) in individuals with inflammatory myelopathies in response to functional electrical stimulation (FES) cycling therapy. The study will also evaluate the changes in CSF growth factors, neurotrophins, and inflammatory cytokines in response to FES stimulation. A correlation between changes in function and changes in the cerebrospinal fluid (CSF) neurotrophic/inflammatory milieu will provide evidence of biochemical changes that may mediate neurological repair following FES cycle therapy. This data will be crucial for the design of a phase 2/3 clinical trial evaluating the efficacy of FES in patients with inflammatory myelopathies.

Eligible Participants

The study is enrolling people with transverse myelitis, neuromyelitis optica, and multiple sclerosis. The study involves coming to Kennedy Krieger Institute in Baltimore MD for a total of 3 weeks. Participants will use the FES bike either once, three times, or five times per week. At the beginning and at the end of the study, you will undergo a detailed clinical exam in addition to blood draw and spinal tap.

Contact Information

If you are interested in participating, please contact Shannon Inches at inches@kennedykrieger.org

Investigator: Adam Kaplin, MD/PhD
Johns Hopkins University School of Medicine, Baltimore, MD

Study Details

This research is being conducted to investigate the epidemiology of cytokine-mediated depression and cognitive impairment in TM subjects compared to MS and non-autoimmune myelopathy controls. Participants will be followed longitudinally to determine if changes in cytokine levels and brain metabolites parallel changes in mood, cognition and neurologic outcomes (6 months follow-up).

Eligible Participants

Study is ongoing, but enrollment is currently on hold.

The study is enrolling acute new onset TM and MS patients between the ages of 18-65 years.

Contact Information

If you are interested in participating, please contact: Allison Riehm at 410-502-0622 or ariehm1@jhmi.edu

Registered Protocol Number: 03-07-03-09

Scientists working to cure diseases often need access to biological samples and information from people with those diseases.  In the case of rare diseases, however, those samples can be hard to come by.  We have teamed up with the Accelerated Cure Project (ACP), to help provide valuable samples and data to scientists who are studying TM, NMO, ADEM, ON, and MS.

Study Details

The Accelerated Cure Project Repository is a collection of biological samples and data from people with Multiple Sclerosis (MS) and other demyelinating diseases, their affected and unaffected relatives, and unaffected, unrelated matched controls. The demyelinating diseases represented are: MS and Clinically Isolated Syndromes (CIS), Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic’s, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON). Combining samples from people with these similar-but-different conditions into a single collection not only saves money due to the efficiency of a single operation, but also enhances research as it allows scientists to easily compare different demyelinating diseases in their studies.

The repository is assembling the largest collection of samples and data from the described population available to date. Click here to see current enrollment status and to learn more.

You can learn more about the research being supported through repository samples and data by visiting here.

Eligible Participants

Enrollment is currently open for individuals diagnosed with NMO.

If you have been diagnosed with NMO and have not already enrolled in the ACP repository, we invite you to learn more about sharing your samples and data with researchers around the world. Participation consists of a blood draw and an extensive interview at either University of Texas at Southwestern in Dallas or Johns Hopkins University in Baltimore. This is not a treatment study. There are no drugs involved. If you have NMO and are unable to travel to one of the two collection sites, a nurse may be available to travel to your town to conduct the study visit there.

Contact Information

If you are interested in participating, please contact the study coordinator at the site of interest. Or you can call ACP’s repository director, Sara Loud, at (781) 487-0032.