Preventing migraine by reducing nasal surface contaminants & restoring nasal mucosa integrity: Clinical efficacy of a new generation of polymeric osmotic treatment- MIG SPRAY

Author(s): Dr. Rémi Shrivastava, Dr. Sayali Sadgune, Mr. Navneet Pathak, Mrs. Séverine Dameron, Mrs Stéphanie Schiphorst, Dr. Ravi Shrivastava

leading cause of years lived with disability worldwide. This is a multifactorial disease with complex pathology involving multiple external and internal triggering factors, nasal mucosa, brain meninges, vascular changes, and abundant secretion of vasoactive peptides and cytokines in the blood and on the nasal surface. A high concentration of GCRP neuropeptide and inflammatory cytokines such as IL-6, IL-12, TNF-α, and TGF-β is found on the nasal surface, generating strong nasal mucosa inflammation and damage.

Objective: Nasal mucosa is one of the key organs playing a role in releasing and accumulating migraine triggering factors, allowing their easy diffusion into the circulation, and generating migraine triggering threshold circulating concentrations. None of the currently available treatments are multi-target, efficient, and free of adverse effects. We conceived a medical device which not only removes continuously these factors from the nasal surface but also cleans and restores nasal mucosa integrity to keep circulating concentrations of these factors below migraine triggering threshold levels.

Methods: This trial included 125 patients having episodic migraine and diagnosed for more than a year for migraines and meeting the migraine criteria as defined in the International Classification of Headache Disorder (ICHD-3 :1.1). Baseline data were collected for 28 days before the start of the three-month treatment period. Patients were randomized in a 1:1 ratio to receive either MIG SPRAY or placebo for a period of 12 consecutive weeks. The primary end point was the mean change in the average number of migraine days per month, comparing the baseline 28-day pre-intervention period with 9 week to 12 week after the first dose of the trial regimen. Secondary endpoints were the percentage of patients with a reduction of at least 50% in the average number of migraine days per month and days of use of any acute headache medication per month. The HIT-6 and MIDAS scores were also evaluated vs. baseline between the two groups.

Results: Compared to baseline, a statistically significant mean reduction in MIG SPRAY vs placebo was observed for the number of migraine days per month, HIT-6 and MIDAS mean scores, without any adverse effect of change in systemic parameters.

Conclusions: MIG SPRAY is a new generation of highly effective polymeric migraine prevention treatment with the advantage of being multi-target, natural, mechanically acting, and totally safe.