The TEALS (Tecfidera in amyotrophic lateral sclerosis) Study is a multi-centre Phase 2 clinical trial to investigate the safety, tolerability and effectiveness of a drug called Tecfidera in people with MND.
Tecfidera is currently used to treat relapsing multiple sclerosis and works by dampening down inflammation. A variety of neuroinflammatory changes occur in people with MND including a reduction in immune cells known as regulatory T cells. Reductions in regulatory T cells have been associated with a rapid rate of disease progression in MND. In animal models of MND, increasing levels of regulatory T cells has been beneficial to survival. In humans, Tecfidera enhances regulatory T cell levels, so the investigators hope to slow down MND disease progression by targeting this pathway.
The TEALS Study will assess if Tecfidera is effective in slowing down disease progression and whether it is safe in MND patients.
The TEALS Study is led by Professor Matthew Kiernan (University of Sydney, Brain and Mind Centre) and Professor Steve Vucic (University of Sydney, Westmead Hospital). The trial commenced 2017 and results are expected late 2020/early 2021. Patient recruitment and treatment has been completed.
The six centres are:
At the time of recruitment, participants must have been diagnosed with sporadic amyotrophic lateral sclerosis for less than two years. In addition, the study will only enrol patients who are on a stable dose of riluzole for at least 30 days prior to the screening visit.
Tecfidera is a tablet taken orally with food. Patients will be randomised into a treatment group and a placebo group so not all participants will receive the active drug. Patients will be assessed for safety, clinical and neurophysiological outcome measures. The study duration will be 42 weeks.
The trial design is described in detail here.
This research will determine if Tecfidera is effective and safe in MND. Analysis of data from the trial will give researchers a clearer picture on whether Tecifdera should be tested in larger studies to further investigate its potential.
For more information, contact Professor Steve Vucic.