The anti-migraine activity of supplement formulation PEATONIDE® combining palmitoylethanolamide and melatoni
Not Applicable
Completed
- Conditions
- Treatment of migraine attacks in subjects affected by episodic migraine (with or without aura)Nervous System Diseases
- Registration Number
- ISRCTN52370199
- Lead Sponsor
- Erbozeta S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Migraine frequency (days of migraine attacks per month) comparing the two-month run-in with the three-month treatment cycles measured using a headache diary daily
- Secondary Outcome Measures
Name Time Method The following secondary outcome variables are assessed during the two-month run-in and the three-month treatment cycles:<br>1. The intensity of migraine attacks measured using a 10-point Likert scale for each migraine attack <br>2. Duration of migraine attacks measured in hours for each migraine attack <br>3. Grade of disability of migraine attack measured using a 3-point Likert scale for each migraine attack <br>4. The amount of analgesics used during migraine attacks measured as dose unit for each migraine attack <br>