MIG SPRAY was developed in collaboration with the European migraine research center NEURO-DOL (Inserm, CHU de Clermont-Ferrand).
Claims
- Decreased migraine frequency from the second month of treatment
- Reduced severity of migraine attacks beginning in the second month
- Reduced need for acute medication
- Enhanced quality of life
Patient's benefits
- Reduction of migraine associated-pain
- Reduced impairment/disability associated with migraine
- Improved daily functioning / functionality - Improved quality of life
- Reduces dependency on acute crisis medication
Product development and research
MIG SPRAY was developed through extensive research into the role of nasal mucosa in migraine pathogenesis. Its formulation leverages an osmotic effect to draw triggering factors away from the nasal lining into an osmotically active solution. This osmotic action also cleanses the nasal cavity and sinuses, helping to relieve nasal congestion and directly addressing the mechanisms involved in migraine attacks.
Mode of action
MIG SPRAY is a nasal spray that helps prevent migraines through two mechanical actions:
- Protective Barrier: When used, MIG SPRAY forms a gentle layer inside your nose. This barrier helps to block out external triggers such as chemicals, pollutants and irritants that can trigger a migraine.
- Relieves Nasal Congestion: MIG SPRAY cleanses the nasal mucosa and alleviates nasal congestion, directly addressing the mechanisms that trigger migraines.
MIG SPRAY 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 studies
#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 migraines, designed to cleanse the nasal mucosa and relieve nasal congestion, directly targeting mechanisms that trigger migraines. Additionally, it forms a gentle protective layer inside the nose, helping to block external migraine triggers.
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 MIG SPRAY 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 MIG SPRAY 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.
# 3 Clinical study in children
This study presents the results of a clinical trial on the clinical efficacy of a MIG SPRAY in children aged seven years and older. The study included 31 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.
MIG SPRAY is a safe and effective preventive treatment for migraines, designed to cleanse the nasal mucosa and relieve nasal congestion, directly targeting mechanisms that trigger migraines. Additionally, it forms a gentle protective layer inside the nose, helping to block external migraine triggers.
Product Details
Warning: The following information is provided for general knowledge purposes only and does not replace the official electronic Instructions for Use (IFU), which will be delivered with the medical device.
- Indication: Used for the prevention of episodic migraines, with or without aura, in adults and children aged seven (7) years and older.
- Composition: Aqua, Glycerol, association of Acacia gum and Xanthan gum, Migcyanidin: association of Salix alba, Curcuma longa, Vitis vinifera, Mentha piperita and Tanacetum parthenium extracts; potassium sorbate, sodium benzoate, citric acid
- Presentation: 15ml Nasal spray.
- Class: MDR Class IIa.
- Precautions: For topical use only (nasal cavity). Keep out of reach and sight of children.
- Exclusions: MIG SPRAY should not be used in certain situations, such as hypersensitivity to any of its ingredients. Additional contraindications are detailed in the instructions for use provided with the medical device.
- Age: 7+.
- Storage conditions: Below 25°C.
- Legal manufacturer: VITROBIO (France).
- Product code: MIG.