Table 2 Summary of trials of melatonin-based therapy for migraine prophylaxis
From: Genetic and biochemical changes of the serotonergic system in migraine pathobiology
Reference | Study design | Cases and migraine type | Daily dose and duration | Primary endpoint | Result |
|---|---|---|---|---|---|
Peres et al., 2004 [122] | open-labelled | Total adults, 32 | 3Â mg/day, 30Â min before bedtime for 3Â months | Percentage of patients with >50% reduction in migraine frequency | positive |
Miano et al., 2008 [123] | open-labelled | Total children, 22 13 MO 1 MA 8 CTTH | 3Â mg/day for 3Â months | Reduced the frequency of headache attacks by >50% from baseline | positive |
Alstadhaug et al., 2010 [124] | randomized, double-blind, placebo-controlled crossover study | Total adults, 46 25 MO 13 MA | 2Â mg/day prolonged release melatonin, given 1Â h before bedtime for 2Â months | Migraine attack frequency (AF) | negative |
Fallah et al., 2015 [125] | open-labelled, non-randomized, uncontrolled | Total children, 60 32 MO 28 MA | 0.3Â mg/kg for 3Â months | Percentage of patients with >50% reduction in migraine frequency | positive |
Bougea et al., 2016 [120] | open-labelled | Total children, 41 12 TTH 37Â M | 4Â mg/day 30Â min before bedtime for 6Â months | Reduced headache frequency | positive |