A drug has been found that is shown to reliably restore brain function that was previously damaged by multiple sclerosis — in human patients. The study gives hope that remyelination is possible. Details come to us from a paper published on Oct. 10, 2017 in The Lancet.
Researchers at the University of California San Francisco (UCSF) tested clemastine fumarate, an antihistimine that was first approved by the U.S. Food and Drug Administration (FDA) in 1977 for allergies, which has been available over the counter in generic form (known to most as Dayhist or Tavist) since 1993. What they found surprised them. Study participants who had long suffered from optic neuritis experienced a measurable improvement in their vision.
“[T]his is the first randomised controlled trial to document efficacy of a remyelinating drug for the treatment of chronic demyelinating injury in multiple sclerosis. Our findings suggest that myelin repair can be achieved even following prolonged damage.”
In the patients in our trial, the disease had gone on for years, but we still saw strong evidence of repair.
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, MD — Debbie and Andy Rachleff Distinguished Professor of Neurology, chief of the Division of Neuroinflammation and Glial Biology, and medical director of the UCSF Multiple Sclerosis and Neuroinflammation Center.
The researchers enrolled patients with RRMS who suffered from optic neuritis whose visual-evoked potentials (VEPs) reflected pre-existing deficits in neural transmission. The researchers showed patterns on a screen to participants and used electrodes to gauge how long it took for the signal be detected. The time from pattern presentation to the detection of the VEP is a measurement of how long it took for the signal to travel via nerve fibers from the retina to the visual areas at the back of the brain.
During the periods when each group was taking the drug (at a dose of 5.36 mg orally twice daily), the neural signal from the eye to the back of the brain was much faster than the baseline measurements taken at the beginning of the study. The effect persisted in the group that had switched to placebo, suggesting that durable repair of myelin had been induced by the drug.
The researchers used a “crossover” design which gave them the ability to compare patients to themselves – a form of control that increases the statistical power of the study by nearly an order of magnitude.
The only noted side effect was fatigue.
Should folks with RRMS start taking 5.36 mg of clemastine fumarate, twice a day for 90 days? Probably not — and definitely not without a physician’s oversight. The maximum recommended dosage for the medication is 2.68mg, three times daily, and this protocol exceeds that.
“This is the first step in a long process,” Green said. “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.”
At the time of writing this article, clemastine fumarate 2.68 mg, 100 tablets can be found online for $69.99 plus shipping, putting the cost of the protocol at less than $3 a day. With RRMS disease modifying drugs running more than $65,000/year or $179/day (and Congress launching a probe into why these drugs are only increasing in cost), it’s anyone’s guess how much this therapy may cost once the FDA approves it for our use.
You may also enjoy reading other articles by Rachael: 5 Ways To Make Your Home MS Friendly, Having The Best Sex Possible With Multiple Sclerosis and Cinnamon Helps To Suppress Symptoms.