Étude clinique MIGSPRAY : Une révolution contre les migraines

MIGSPRAY clinical study: A revolution against migraines

Oct 24, 2023

The ongoing research to combat migraines has seen a major breakthrough with the development of MIGSPRAY, an innovative and effective treatment. This breakthrough was made possible by the combination of research on parthenolide and technologies developed by the VITROBIO laboratory.

MIGSPRAY Treatment

MIGSPRAY is a class I medical device in the form of a nasal spray, intended for the prevention of migraine attacks. The natural active ingredients are included in a glycerol base, made film-forming thanks to the addition of specific polymers. Applied nasally, this film-forming glycerol maximizes the effects obtained in patients due to its osmotic properties. These allow fluids to be attracted to the outside once applied to the nasal mucosa, thus leading to the drainage of proteins involved in migraine such as CGRP, certain interleukins or TNF-alpha.

Clinical Results

Clinical results show that MIGSPRAY has remarkable efficacy. The study was divided into four main parts:

  1. Pathophysiology of Migraine: The study highlights the absence of specific preventive treatment for migraine, highlighting the importance of targeting pro-inflammatory proteins.

  2. In Vitro Study: It made it possible to justify the selection of specific polymers to target the proteins involved in triggering migraine attacks.

  3. Observational Clinical Study: Carried out on 256 patients, it showed a significant improvement in the prevention of migraine attacks.

  4. Randomized Double-Blind Clinical Study: Comparing MIGSPRAY to a placebo in 125 patients, it confirmed the efficacy of the treatment.

Conclusion

Clinical results highlight the efficacy of MIGSPRAY in reducing the number of migraine days per month, a significant improvement in HIT-6 and MIDAS scores, as well as excellent treatment tolerance with no serious side effects reported. These results make MIGSPRAY a revolutionary treatment option in the fight against migraines.

Demographic Data and Clinical Study Results

  • Demographic data showed no significant differences between treatment and placebo groups, ensuring a fair comparison.
  • MIGSPRAY demonstrated a statistically significant reduction in the number of migraine days per month.
  • 58% of patients in the treatment group experienced at least a 50% reduction in the average number of migraine days per month, compared to 24% in the placebo group.
  • HIT-6 and MIDAS scores showed significant improvement in the treatment group compared to the placebo group.
  • No serious side effects were reported, confirming the safety of the treatment.

Side Effects and Safety

MIGSPRAY was shown to be a safe treatment, with no serious side effects reported. The minor side effects observed showed no significant difference between the treatment and placebo groups, thus reinforcing confidence in the safety of the product.

Conclusion

MIGSPRAY represents a significant advance in migraine attack prevention, providing patients with a natural and effective treatment option. Clinical results strongly support its efficacy and safety profile, making MIGSPRAY a promising option for the millions of people affected by migraine worldwide.

Link to the clinical study : https://www.openaccessjournals.com/articles/preventing-migraine-by-reducing-nasal-surface-contaminants--restoring-nasal-mucosa-integrity-clinical-efficacy-of-a-new-generation-16110.html

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