Tonix Pharmaceuticals has enrolled the first participant in the Phase II PREVENTION study of intranasal potentiated oxytocin (TNX-1900) to prevent migraine headaches in chronic migraineurs.

The multicentre, double-blind, placebo-controlled, randomised Phase II PREVENTION study has been designed for assessing the safety and efficacy of TNX-1900 given prophylactically daily for preventing chronic migraine.

It intends to enrol a total of 300 participants across approximately 25 sites in the US.

The trial will have three arms, with two TNX-1900 treatment regimens and one placebo in a 1:1:1 ratio.

It will have a 12-week double-blind Treatment phase with the study drug, following a four-week Run-In phase to confirm that chronic migraine criteria are being met. This will be followed by a two-week safety Follow-up phase.

The mean change in the number of migraine headache days between the 28-day Run-In phase and the last 28-days of the Treatment phase is the trial’s primary efficacy endpoint.

The mean change in a migraine-specific quality of life measure, proportion of patients with a ≥50% reduction in the number of migraine headache days, and the mean change in the number of days using migraine abortive medications will be the important secondary efficacy endpoints of the trial.

After the first 50% of enrolled participants conclude the trial, an interim analysis is expected to be completed.

Tonix Pharmaceuticals CEO Seth Lederman said: “Despite several classes of migraine preventatives available, there remains an unmet need for novel approaches, with an estimated four million individuals in the United States suffering from chronic migraine, often a seriously disabling condition.

“TNX-1900 has a unique, multimodal mechanism of action that includes an ability to inhibit the release of the trigeminal sensory neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining, and the brainstem, and to suppress signalling in pain neurons.

“TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition.”

The company expects to receive data from a planned interim analysis in the fourth quarter of this year.