Treatment of migraine attacks in subjects affected by episodic migraine (with or without aura) Nervous System Diseases
Conditions
Interventions
All included patients are treated with a formulation consisting of 1200 mg of hydrodispersible PEA and 0.2 mg of melatonin (PEATONIDE®) or with a placebo by oral administration taken every evening at
number of days per month taking any analgesic for migraine in the previous month
intensity, duration and grade of disability of migraine attacks
presence of aura
presence of associated symptoms (nausea, vomiting, photophobia, and phonophobia). The intensity and disability of migraine attacks are rated on a 10-point and a 3-point Likert scale, respectively.
Sponsors
Erbozeta S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. Diagnosis of episodic migraine (with or without aura) for at least one year before recruitment according to IHS-3 criteria 3. At least two migraine attacks for at least three months before recruitment
Exclusion criteria
Exclusion criteria: 1. Inconsistent supplement intake 2. Regular uptake of analgesic drugs for more than 12 days per month 3. Treatment with other supplements, or drugs, potentially having preventive effects on migraine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine frequency (days of migraine attacks per month) comparing the two-month run-in with the 3-month treatment cycles measured using a headache diary daily | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome variables are assessed during the two-month run-in and the 3-month treatment cycles: 1. The intensity of migraine attacks measured using a 10-point Likert scale for each migraine attack 2. Duration of migraine attacks measured in hours for each migraine attack 3. Grade of disability of migraine attack measured using a 3-point Likert scale for each migraine attack 4. The amount of analgesics used during migraine attacks measured as dose unit for each migraine attack | — |
Countries
Italy
Contacts
Public ContactGian Carlo Tenore
Outcome results
None listed