ULTRAMICRONIZED PALMITOYLETHANOLAMIDE REDUCES FREQUENCY AND PAIN INTENSITY IN MIGRAINE. A PILOT STUDY

The aim of this open study is to verify whether treatment with ultra-micronized palmitoylethanolamide can reduce headache frequency and intensity in patients suffering from migraine when used in migraine preven-tion. Fifty patients, suffering from migraine without aura, for at least 6 months with a frequency of monthly crises from 3 to 8 and with presence of headache from 4 to12 days per month, were treated sublingually with ultra-micronized palmitoylethanolamide microgranules 600 mg bid for 3 months. The primary endpoint was reduction in headache days per month; secondary endpoint was duration and intensity of pain crisis and number of analgesics taken per month and changes of thermographic patterns. All the considered parameters significantly improved at the end of treatment. The mean number of days per month with migraine significantly decreased (p < 0.0001); pain intensity was significantly (p < 0.0001) miti-gated; the number of analgesics taken significantly decreased and the thermographic patterns showed a reduction of hypothermia as well as the response to trigger factors. No serious adverse events have been observed. Despite the limitations of the study due to its open-label nature it would be desirable to confirm with further clinical trials the ultra-micronized Palmitoylethanolamide effect in migraine prevention.