Clinical trial of flupirtine maleate in patients with migraine

Abstract

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.

Kv7 Channels as Targets for the Treatment of Pain

“…For post-episiotomy pain, flupirtine was superior to suprofen and for post-traumatic sports injury pain it was superior to paracetamol plus massage [74]. In one controlled trial in migraine patients there was a trend for flupirtine efficacy [78]. Preliminary anecdotal evidence for efficacy of flupirtine in the treatment of a small number of refractory fibromyalgia patients has also been reported [79].…”

“…Furthermore, compound (67) was tested intravenously in a rat model of acute migraine, where it exhibited a dose-dependent reduction in the superior sagital sinus-stimulated, trigeminal field response [97]. Table 9, extrapolation from the oxindole structure of BMS-204352 led to a collection of compounds containing a quinolinone core (73)(74)(75)(76)(77)(78)(79) that when appropriately functionalized activated Kv7.2 channels [98]. Compound (79) was identified as the most potent Kv7.2 agonist in this series with an EC 50 of 663nM.…”

Kv7 Channels: Function, Pharmacology and Channel Modulators

“…In a double-blind randomized parallel group study [141] the effect of flupirtine (100 mg) was assessed in 20 patients with acute migraine attacks and compared to the effects of paracetamol in a second group of patients. Over five days there was some evidence that flupirtine was more effective in reducing pain and time spent in bed, although patients taking flupirtine showed a higher incidence of pain on the first day.…”

Paracetamol und Metamizol in der Therapie chronischer Schmerzen

“…In den Studien der Tabelle 1 (Migränepatienten) [27,30,32,33] war Paracetamol ohne Einschluß einer Plazebogruppe mit anderen Analgetika verglichen worden. Die prinzipielle Wirksamkeit des Paracetamols und Vergleichsanalgetikums war entweder nicht untersucht [27,30] oder aus der Abnahme der Schmerzintensität abgeleitet worden [32,33], eine fragwürdige Aussage bei einem Anfallsschmerz mit Spontanrückbildung.…”

“…Die prinzipielle Wirksamkeit des Paracetamols und Vergleichsanalgetikums war entweder nicht untersucht [27,30] oder aus der Abnahme der Schmerzintensität abgeleitet worden [32,33], eine fragwürdige Aussage bei einem Anfallsschmerz mit Spontanrückbildung. Lediglich in der Studie von Miller et al [26] an Patienten mit chronischem Spannungskopfschmerz wurde eine Plazebogruppe mitgeführt.…”