Journal of Clinical Trials
Open Access

Abstract

Proof-of-Principle, Open-Label Prospective Cohort Trial of a Novel Nutraceutical for the Prevention of Refractory Migraine

Frank Comhaire and Jacques De Reuck

Objective: To estimate the possible effectiveness of a novel nutraceutical for the prevention of attacks of migraine.

Materials and methods: Six months open-label “proof-of-principle” prospective cohort trial in 15 consecutive patients with refractory migraine using a novel nutriceutical.

Results: Five patients were considered non-responders. In the 10 responders the mean number of episodes decreased from 12.3 (SD: 6.6) in the 6 months before treatment to 3.6 (SD: 3.2) during treatment (p=0.002), the mean duration of attacks decreased from 1.75 (SD: 0.63) days to 0.95 (SD: 0.44) days (P=0.016), and the total number of days with migraine per month decreased from mean 3.13 (SD: 1.42) to 0.54 (SD: 0.52)(P=0.002), corresponding to a diminution of 74%. Comparison of responders and non-responders revealed patients with 21 or more attacks in the 6 months before treatment not to improve.

Conclusion: This preliminary trial suggests the intake of the novel nutraceutical to significantly reduce the burden of migraine in two thirds of patients with refractory disease, particularly in subgroups with 21 or less episodes in 6 months.