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MIG SPRAY : preventive treatment for headaches & migraines


MIGSPRAY is an innovative, nasally-applied medical product designed to alleviate the symptoms of migraines. It works by using an osmotic mechanism to draw out fluids from the highly vascular nasal cavity, along with key proteins involved in triggering migraines.

The MIGSPRAY’s glycerol film then traps these proteins, reducing their potential to cause a migraine. Furthermore, MIGSPRAY’s osmotic action assists in cleaning the nasal cavity and sinuses, a feature that is beneficial considering the role of nasal congestion in migraines.

Its effectiveness and safety have been confirmed through two clinical studies, showing efficacy from the second month of treatment and reporting no severe adverse effects.


Clinical trial

Randomized, double-blind, placebo-controlled trial

Population

This product is intended for adult use

Indication

Preventive treatment for headaches and episodic migraines

Overview


MIGSPRAY is an innovative preventive treatment for migraines, using a nasal spray format. This device acts through a unique osmotic mechanism and targets the proteins involved in the occurrence and development of migraine attacks.


MIG SPRAY was developed in collaboration with the European migraine research center NEURO-DOL (Inserm, CHU de Clermont-Ferrand).


Product development and research

MIGSPRAY was developed based on extensive research on the role of proteins in migraine pathogenesis. The product is specifically designed to target proteins such as CGRP, interleukins 6 and 12, or TNF α, which have been implicated in the onset of migraines. It is formulated to exert an osmotic effect, drawing these proteins away from the nasal lining into an osmotically active solution. Furthermore, the osmotic action of the spray helps clean the nasal cavity and sinuses, which can also aid in relieving the symptoms of migraines.

 

Mode of action

 

1 > Protective barrier

Migraine patients are sensitive to contaminants, allergens, odors, chemical molecules, etc. that can trigger an attack. The film created by MIG SPRAY acts as a protective barrier.

2 > Effect on migraine proteins

The osmotic action created by the film attracts CGRP and interleukins present in the nasal bloodstream. Gradually, the concentration decreases and limits the intensity of migraines.

3 > Promotes oxygenation

The osmotic action allows to drain the sinuses and to decongest the nose. This effect allows a better oxygenation of the brain and limits the occurrence of attacks.


MIGSPRAY is a promising preventive treatment for migraines. Its unique mechanism of action, combined with clinical evidence demonstrating its efficacy and safety, make it a valuable addition to the therapeutic options for migraine management. Future research can further shed light on its potential applications and benefits.



Clinical Trial x3


#1  Randomised, double-blind, placebo-controlled clinical trial


This study presents the results of a clinical trial on the clinical efficacy of a MIG SPRAY. The study included 125 patients suffering from episodic migraines, who were randomised to receive either MIG SPRAY or a placebo for a period of 12 weeks. The results showed a statistically significant reduction in the number of migraine days per month in patients treated with MIG SPRAY compared with the placebo group. In addition, no adverse effects were observed. MIG SPRAY is a safe and effective preventive treatment for migraine, which works by eliminating migraine triggers from the nasal surface and restoring the integrity of the nasal mucosa.



See full publication (PDF)


Main results


FREQUENCY

  • 21% reduction in migraine attacks after 2 months and 23% after 3 months. 

Propranolol, the most widely prescribed prophylactic drug, reduces the frequency of attacks by an average of 26% after 3 month .

  • 22% of patients had at least a 50% reduction in the frequency of their attacks.

OTHER PARAMETERS

  • 40% reduction in crisis intensity*
    MIDAS test : Migraine disability assessment is used to assess the quality of life of migraine sufferers.


  • 50% reduction in the use of crisis medication (triptan) after 3 months of treatment.


  • Reduction in HIT6 score of 8.3 points. The HIT-6 score for Headache Impact Test is a standardised test for assessing migraine.. In comparison, propranolol increases the score by around 10 points.  


#2 Clincal study - real life data

This real-world observational study, conducted over three months, involved 322 patients aged 12-55 who experienced frequent migraines. The study demonstrated that MIGSPRAY significantly reduced the number of migraine days by 26%, as well as the intensity and duration of attacks. Patients also reported improvements in disability scores, showing that MIGSPRAY effectively enhances quality of life by reducing the burden of migraines.

These results confirm the findings of prior clinical trials, positioning MIGSPRAY as a valuable, safe, and well-tolerated option for migraine prevention.

See full clinical trial


# 3 Clinical study in children

second clinical study in children is currently underway. This study will enable MIG SPRAY to be used from the age of 3, with an adapted dosage. Results expected in 2024

 



Product Details


  • Indication: Filmogen liquid bandage for the prevention of migraine.
  • Composition: Filmogenic glycerol, water, association of Vitis vinifera, Curcuma longa, Tanacetum parthenium, Salix alba, and Mentha piperita, potassium sorbate, sodium, and citric acid.
  • Presentation: Nasal spray 15ml.
  • Class: MDR Class IIa.
  • Direction: Apply 2 sprays in each nostril, 2-3 times a day.
  • Precautions: For topical use only (nasal cavity). Keep out of reach and sight of children.
  • Age: 7+.
  • Storage conditions: Below 25°C.
  • Legal manufacturer: VITROBIO (France).
  • Product code: MIG.