pharmafileOctober 16, 2017
The results of a study from the University of California, San Francisco will be welcomed with a certain excitement from all quarters, given that it seems to show the repair of myelin damaged by multiple sclerosis (MS) and, to add to the news, is achieved through the use of a generic allergy medication.
The Phase 2 clinical trial showed that an antihistamine was able to restore nervous system function in patients with chronic MS. The treatment would be the first that had the potential to reverse damage inflicted by the demyelinating disease.
In people who suffer from MS, the immune system begins to attack the myelin sheath that protects nerves from damage. This can disrupt nerve function, meaning that the signals passing along the nervous system can be slowed or disrupted.
This leads to symptoms that include fatigue and difficulty walking. People who suffer from the condition generally have a lower life expectancy, as a result of the condition.
In the trial, researchers tested the use of clemastine fumarate to see whether the treatment would show benefits to the visual system, which is often the first to be affected by the condition. This was analysed through showing participants flickering patterns on a screen and then using electrodes placed over the brain’s visual areas at the back of the head to determine how quickly the brain generated a response.
This method, known as visual evoked potentials (VEPs), is a common measure to determine whether there is any change in the speed with which nerves are able to conduct messages. The results found that the speed with which the neural signal traversed from the eye to the back of the brain was significantly increased.
As part of the trial construction, over the five month period, patients were given first either placebo or the drug for 90 days, at which point the participants were switched to receiving the opposite. The study found that this effect persisted even when patients were switched to placebo, suggesting that the drug had provided durable repair of the myelin.
"To the best of our knowledge this is the first time a therapy has been able to reverse deficits caused by MS. It’s not a cure, but it’s a first step towards restoring brain function to the millions who are affected by this chronic, debilitating disease," said the trial’s principal investigator, Ari Green.
He continued, "This is the first step in a long process…By no means do we want to suggest that this is a cure-all. We want to ground-truth myelination metrics – we’re designing the crucible that’s going to be used to test any future method for detecting remyelination."
The next step will be to increase the scale of the trial. With the drug already FDA approved, if it can continue to show benefit in larger trials then the treatment could rapidly reach patients in need.
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