Medical devices · Private label
MigsprayPrevention of
episodic migraine
A nasal approach to migraine prevention, from age 3. Migspray is a nasal spray for the prevention of episodic migraine, with or without aura, in adults and children aged 3 and over. Used regularly between attacks, it helps reduce migraine days and their impact on daily life.
Developed in partnership with INSERM's Neuro-Dol laboratory, which specialises in migraine research, and Clermont-Ferrand University Hospital, this medical device offers a preventive approach without pharmacological action. Supplied as a nasal spray of 15 ml, with carton and instructions for use, Migspray is made in France and available to market under your brand.
Your migraine product,
under your brand
4 clinical studies
505 participants analysed in total, across all groups.
Population
Adults and children aged 3 and over.
Indication
Prevention of episodic migraine, with or without aura.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Helps reduce the number of migraine days.
- Helps reduce the impact of migraine on daily life.
- Helps reduce the need for acute migraine medication.
- Cleans and protects the nasal mucosa against irritants.
- Suitable for adults and children aged 3 and over.
- 100% plant-derived ingredients.
Mode of action
A preventive approach based on gradual desensitisation of the trigeminovascular system.
Through its film-forming glycerol technology, Migspray acts locally on the nasal mucosal environment. It helps reduce peripheral stimuli that sustain hyperreactivity of the trigeminovascular system involved in triggering migraine attacks.
This local physical action gradually supports a less stimulating environment for this system. Used regularly between attacks, Migspray thus helps reduce migraine frequency and its impact on daily life.
Clinical programme · Episodic migraine
Clinical study
4 clinical studies, with 505 participants analysed in total across all groups. The programme includes two placebo-controlled trials, a real-world study and a hospital tolerability study.
Selected results from the placebo-controlled trial in 120 adults aged 18 to 55 with episodic migraine. The table shows mean reductions from baseline during weeks 9 to 12.
| Benefit assessed | Migspray | Placebo | Between-group comparison |
|---|---|---|---|
| Fewer migraine days per month | −1.4 days | −0.4 days | p < 0.001 |
| Lower headache impact — HIT-6 | −8.3 points | −1.8 points | p < 0.001 |
| Less impact on activities — MIDAS | −6.6 points | −2.1 points | p < 0.001 |
Migraine days are counted over 28-day periods. The HIT-6 measures the impact of headaches on daily life. The MIDAS assesses activities missed or substantially reduced because of migraine. Lower scores indicate improvement.
Good tolerability observed in the studies.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Migspray is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | MIG |
| Public name | Migspray |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Adults and children aged 3 and over |
| Category | Migraine |
| Full official indication | Prevention of episodic migraine, with or without aura, in adults and children aged 3 and over |
| Composition | Film-forming glycerol, Migcyanidin |
| Format / volume | 15 ml nasal spray, with carton and instructions for use |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture; do not refrigerate or freeze |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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