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.
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.
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.
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.
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.