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Active Clinical Trials at UT 2018

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Active Clinical Trials at UT 2018
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Clinical trials or clinical studies are tests of new treatments to determine whether they are effective and safe.  This work is essential for developing new and better medicines for MS, and is a large part of what we do.  The new treatment is tested against either an inactive treatment (placebo) or against an existing treatment.  Usually the trials are blinded, which means the physician and the patient don't know which treatment they are on, and randomized, which means subjects are assigned to the treatment groups in a random fashion.  Most studies in MS are expensive, and are funded by one of the large pharmaceutical companies that are developing a new treatment.  We have been in several clinical trials in the past, and are currently participating in about 10.  The ones that are actively recruiting new patients are listed below.  
 
If you are interested in being part of any of these studies, please contact Jim Jemelka at  James.R.Jemelka(at)uth.tmc.edu

Affinity Trial—Biogen

This study is exciting because it is one of the first medicines that are supposed to help repair myelin.  The study drug binds to a molecule on myelin and is supposed to make the myelin more likely to grow back after damage.  Previous studies had some promising results. 

Key inclusion/exclusion criteria are:  age 18 to 58, relapsing or secondary progressive MS, mild to moderate disability (walking with a cane ok), some disease activity in the last 2 years but no relapses in the last 6 months, on stable treatment with any interferon or Tecfidera or Tysabri. 

This is an add-on trial.  You will stay on your current treatment and add the study medicine.  The study drug is given once a month, and half the subjects will be on placebo.  After initial screening, you will have a MRI scan to determine if you have areas of myelin with the potential for regrowth. 

ATA188—Atara Biotherapeutics

This study will test whether giving additional T cells specific for Epstein-Barr virus (EBV) is beneficial in MS.  There is a lot of evidence linking EBV to MS, and everyone with MS is infected with EBV.  Once you are infected, EBV stays in your B lymphocytes for the rest of your life.  The idea of this study is that reducing the number of EBV infected cells will reduce the disease activity in MS.  I have been working on the role of EBV in MS for years, so I find this a really interesting approach. 

This is a phase I study, meaning that it is the first time this treatment has been tested in humans.  Atara has developed T lymphocytes that are specific for EBV that will kill EBV infected cells.  There has been a small previous study with promising results, and they are also testing this treatment in other EBV related diseases.  The cells are given iv at 2 week intervals for a total of 6 infusions.  They will start with a small dose, and gradually increase the dose in several steps. 

They are enrolling relapsing MS patients age 18 to 45 or progressive MS patients age 18 to 65.  You must have at least mild disability, but still be able to walk 100 yards with a cane.  You cannot be on other disease modifying treatment. 

This study will include only a small number of subjects, and the primary aim is to demonstrate that the treatment is safe and to determine the maximum tolerated dose.  There will also be MRI scans and clinical evaluations to look for any benefit from this treatment. 

Alkermes

This is a study to compare side effects and effectiveness of monomethyl fumarate and dimethyl fumarate.  The dimethyl form is currently marketed as Tecfidera.  The monomethyl fumarate (MMF) is expected to have the same benefits for MS but less side effects.  In this study, all subjects will be on an active treatment, either Tecfidera or MMF for a short period, after which all subjects will switch to open label treatment with MMF. 

This study is worth considering for anyone starting treatment with Tecfidera. 

Neuromyelitis optica—Medimmune study

This is a study of a treatment that depletes B lymphocytes for neuromyelitis optica.  We use such treatments routinely for NMO, but they have never been demonstrated to work.  This study aims to do that for the first time.  Subjects need to have a diagnosis of NMO and a relapse in the last 2 years.  Two thirds of subjects will be on the active treatment from the start of the study, and one third will start on placebo.  After the first 6 months, all subjects will be on the active drug. 

J. William Lindsey, MD
University of Texas Multiple Sclerosis Research Group
Houston, Texas

copyright 2007-2018 John William Lindsey