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An experimental drug for the most severe forms of multiple sclerosis has slowed brain shrinkage by nearly a half.

There are dozens of therapies approved for the relapsing form of MS, a disease of the nervous system, in which people can be symptom-free for months before another attack. But there are very few for people suffering from more severe forms of the disease 鈥� known as primary progressive and secondary progressive MS and in which there is rarely any respite from disabling symptoms.

A clinical trial has now published its results, showing that the drug ibudilast slowed brain shrinkage in progressive MS by 48 per cent compared with a placebo. Loss of brain tissue is a marker of disease progression.

In these forms of the disease, the ongoing breakdown of protective myelin around the brain鈥檚 nerve fibres leads to slower nerve signals which can ultimately result in muscle weakness and problems with balance and vision.

鈥淲e don鈥檛 really know the biological mechanisms that lead to progressive multiple sclerosis, or indeed why this drug is acting on them,鈥� says Robert Fox at the Cleveland Clinic in Ohio. He led a phase II trial of ibudilast, a drug that inhibits proteins that can result in central nervous system inflammation.

The trial included 255 participants from the US, 126 of whom were given a placebo instead of the drug. Each person took up to 10 capsules per day for 96 weeks 鈥� which amounted to 100 milligrams of ibudilast a day for those on the drug 鈥� and underwent MRI brain scans every six months to measure their brain鈥檚 volume. Those scans were used to create a 3D image of the brain which was analysed by computer to tell brain matter apart from cerebral spinal fluid or blood vessels.

Brain loss

Over the 96-week trial, the researchers found that on average, patients taking ibudilast had 2.5 millilitres less loss in brain matter volume than those on the placebo.

鈥淥ne thing to keep in mind is that no one has no brain shrinkage. We expect there to be some just due to normal aging,鈥� Fox says. 鈥淏ut these patients, they have more brain now than they would have had without being on ibudilast.鈥�

Side effects reported by the participants were gastrointestinal symptoms, headache, and depression. Fox says further trials are needed, but the results are promising. 鈥淲e now only have one drug approved for primary progressive MS, and in its trial, it showed 17.5 per cent slowing of brain atrophy. It鈥檚 hard to compare from one trial to another, because they are set up differently, but if the findings of our phase II trial are confirmed in phase III, this would be a great addition to provide treatment,鈥� he says.

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