Clinical trial of flupirtine maleate in patients with migraine.

A double-blind randomized parallel group trial was carried out in two centres to study the drug treatment of acute attacks of migraine. One group of 20 patients was treated with oral doses of 100 mg flupirtine maleate and another group of 20 patients with doses of 1 g paracetamol. In all cases, doses were taken as required up to a maximum of 4 doses per day for 5 days. The total consumption of analgesics was very similar in the two groups (flupirtine group 6.65 +/- 1.14 doses, paracetamol group 6.85 +/- 1.05 doses), as was the incidence of nausea and/or vomiting on each day of the attack. Despite an initial pain level on the first day of the migraine attack which was significantly higher in the flupirtine group, there were trends for flupirtine patients to show subsequently lower pain scores and to suffer less restriction of working ability and confinement to bed. Symptoms and possible side-effects were minor and infrequent in both treatment groups. Four symptoms were reported by 4 patients during flupirtine treatment and 7 symptoms by 5 patients during paracetamol treatment.

RCT Entities:   Population Interventions Outcomes