A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected.
The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices through a Coverage with Evidence Development framework.
As revealed last month, the trial will be double-blinded, randomized and feature a follow-up of at least one year, the company said.
New data, revealed in a posting on Clinicaltrials.gov, indicate that the trial will seek 1,000 subjects with an estimated start date of this July. LivaNova said last month that it only planned to include 500 subjects in the trial of the device.
All subjects in the trial will be implanted with the VNS system, though subjects in the sham-control arm will not have the device activated for the first 12 months. After the initial trial, patients in the sham arm will be allowed to join the open-label, prospective and longitudinal portion of the study where they will tracked out to five years.
The primary endpoint of the trial will be mainly monitored through scoring on the Montgomery Åsberg Depression Rating Scale, as well as disability assessments, adverse event monitoring and a selection of other physical and mental health assessment criteria.
Last November, CMS proposed a launch of a clinical trial of the VNS system to explore its ability to treat Treatment-Resistant Depression.