Cala Health yesterday presented top-line data from a study of its Cala Trio therapy for treating essential tremor.
Trio is a wrist-worn neuromodulation device designed to stimulate nerves responsible for the tremor to provide symptomatic relief. Burlingame, Calif.-based Cala Health said its Prospect trial, which is touts as the largest ever conducted for essential tremor, met its co-primary and secondary endpoints at three months compared to baseline.
The 263-patient single-arm trial studied subjects with an average ET symptom duration of more than 25 years, who used the Trio device in twice-daily, 40-minute sessions for three months. Sixty-two percent of patients showed improvement from severe/moderate to mild/slight according to the Essential Tremor Rating Assessment Scale. Using a different scale, the Bain & Findley Activities of Daily Living score, 68% of patients improved from severe/moderate to mild, the company said.
Secondary endpoint analysis showed that 54% of patients experienced greater than 50% improvement in tremor power over the three months. Transient device-related adverse events such as wrist discomfort, skin irritation or pain occurred in 18% of patients, but no medical intervention was required.
“We are thrilled with the results of the Prospect trial,” founder & CSO Kate Rosenbluth said in prepared remarks. “It is tremendously exciting to see the relief our non-invasive neuromodulation therapy brings to patients with ET, without surgery or drugs. We are deeply grateful to the patients and investigators who participated in this study.”
“In the prospective Prospect trial, we found that 68% of patients showed significant improvement in hand tremor after wearing the Cala therapy for three months, as measured by the ADL assessment scale,” added Dr. Stuart Isaacson, of the Parkinson’s Disease and Movement Disorders Center in Boca Raton. “For patients living with ET, this means that they can now more easily complete daily tasks such as handwriting, drinking from a glass, and using a soup spoon – tasks that were otherwise much more difficult. The therapy is calibrated to each patient’s hand tremor. When activated, it gently stimulates the nerves at the wrist, which interrupts the tremulous circuit in the brain and results in tremor reduction. Treatment with Cala Trio represents a novel approach to improving tremor in people living with ET and provides a safe and effective therapeutic option.”