Efficacy and safety of tonabersat, a gap-junction modulator, in the acute treatment of migraine: a double-blind, parallel-group, randomized study

TY - JOUR

T1 - Efficacy and safety of tonabersat, a gap-junction modulator, in the acute treatment of migraine: a double-blind, parallel-group, randomized study

AU - Dahlöf, C G H

AU - Hauge, A W

AU - Olesen, J

AU - Dahlöf, C G H

AU - Hauge, Anne Werner

AU - Olesen, Jes

N1 - Keywords: Adult; Analgesics; Benzamides; Benzopyrans; Double-Blind Method; Female; Humans; Male; Migraine Disorders; Safety; Serotonin Agonists; Sumatriptan; Treatment Outcome

PY - 2009

Y1 - 2009

N2 - The ability of tonabersat to relieve the symptoms of migraine attacks with or without aura was evaluated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients received 20 or 40 mg of tonabersat, or 50 mg of sumatriptan (positive control), or placebo at the onset of a moderate or severe attack. Headache intensity, relief and recurrence were recorded for 24 h after dosing. On the basis of primary or secondary efficacy measures, tonabersat did not provide a clinically or statistically significant advantage over placebo. Tonabersat generally was well tolerated and had no effect on vital signs, electrocardiogram recordings or laboratory values. The lack of efficacy may be a function of the slow absorption of tonabersat. As a consequence of slow absorption, daily administration of tonabersat as prophylaxis for migraine attacks is under investigation in ongoing studies.

AB - The ability of tonabersat to relieve the symptoms of migraine attacks with or without aura was evaluated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients received 20 or 40 mg of tonabersat, or 50 mg of sumatriptan (positive control), or placebo at the onset of a moderate or severe attack. Headache intensity, relief and recurrence were recorded for 24 h after dosing. On the basis of primary or secondary efficacy measures, tonabersat did not provide a clinically or statistically significant advantage over placebo. Tonabersat generally was well tolerated and had no effect on vital signs, electrocardiogram recordings or laboratory values. The lack of efficacy may be a function of the slow absorption of tonabersat. As a consequence of slow absorption, daily administration of tonabersat as prophylaxis for migraine attacks is under investigation in ongoing studies.

U2 - 10.1111/j.1468-2982.2009.01975.x

DO - 10.1111/j.1468-2982.2009.01975.x

M3 - Journal article

C2 - 19723121

SN - 0333-1024

VL - 29

SP - 7

EP - 16

JO - Cephalalgia

JF - Cephalalgia

IS - Suppl 2

ER -