Newron’s pilot restless legs study proves successful

Safinamide was also found to be well tolerated and did not exhibit any clinically relevant side-effects in patients with restless legs syndrome (RLS), a neurological disorder characterized by jerky movements of the lower extremities which appear mostly in the evening and during sleep.

“We found that treatment with safinamide improved RLS symptoms. Sleep architecture was not modified; conversely sleep fragmentation was positively influenced, as this is often the most distressing aspect of the disorder. The treatment was very well tolerated and did not result in any clinically relevant side effects,” said Professor Luigi Ferini Strambi, head of the Sleep Disorders Center at San Raffaele Hospital, Milan and study director.

“These positive results, in particular the outcome of the polysomnografic studies, appear important in reference to the currently used dopaminergic drugs. On this basis safinamide deserves further exploration as a novel approach in the treatment of RLS,” he concluded.

At present, only two drugs are approved specifically for the treatment of RLS, and these drugs are only available in specific countries. Based on the positive early data, Newron intends to continue its evaluation of safinamide and is currently planning larger clinical trials.