Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study

Abstract

Medication-overuse headache (MOH) represents a severely disabling condition, with a low response to prophylactic treatments. Recently, consistent evidences have emerged in favor of botulinum toxin type-A (onabotulinum toxin A) as prophylactic treatment in chronic migraine. In a 12-week double-blind, parallel group, placebo-controlled study, we tested the efficacy and safety of onabotulinum toxin A as prophylactic treatment for MOH. A total of 68 patients were randomized (1:1) to onabotulinum toxin A (n = 33) or placebo (n = 35) treatment and received 16 intramuscular injections. The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day period ending with week 12. No significant differences between onabotulinum toxin A and placebo treatment were detected in the primary (headache days) end point (12.0 vs. 15.9; p = 0.81). A significant reduction was recorded in the secondary end point, mean acute pain drug consumption at 12 weeks in onabotulinum toxin A-treated patients when compared with those with placebo (12.1 vs. 18.0; p = 0.03). When we considered the subgroup of patients with pericranial muscle tenderness, we recorded a significant improvement in those treated with onabotulinum toxin A compared to placebo treated in both primary (headache days) and secondary end points (acute pain drug consumption, days with drug consumption), as well as in pain intensity and disability measures (HIT-6 and MIDAS) at 12 weeks. Onabotulinum toxin A was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. Our data identified the presence of pericranial muscle tenderness as predictor of response to onabotulinum toxin A in patients with complicated form of migraine such as MOH, the presence of pericranial muscle tenderness and support it as prophylactic treatment in these patients.Electronic supplementary materialThe online version of this article (doi:10.1007/s10194-011-0339-z) contains supplementary material, which is available to authorized users.

Onabotulinum toxin A for treatment of chronic migraine with medication overuse

“…Onabotulinum toxin A has been reported to improve pain in several conditions including migraine [3][4][5]. Various onabotulinum toxin A dosages and injection paradigms have been evaluated in several recent studies and the PREEMPT protocol evolved from these preceding paradigms, by showing definitely that onabotulinum toxin A is a safe, well-tolerated and effective headache prophylactic treatment for chronic migraine [6].…”

Treatment of medication overuse headache—A review

“…53,54 In general, OBTA was better tolerated than AEDs. 50 The adverse events related to OBTA were mainly neck pain, muscle weakness, facial paresis, eyelid ptosis, muscle tightness, and pain at injections sites.…”

“…51 The adverse events related to OBTA were mainly neck pain, muscle weakness, facial paresis, eyelid ptosis, muscle tightness, and pain at injections sites. 53,54 In general, OBTA was better tolerated than AEDs.…”

Update on Medication-Overuse Headache and Its Treatment

“…The role of re-prophylaxis is still controversial. Prophylactic treatment with onabotulinumtoxinA and topiramate in chronic migraine with MOH (see below) has proven effective in placebo-controlled studies, with a significant reduction of headache days per month [34][35][36][37]. However, these results have proven not superior to detoxification without prophylactic treatment in some studies [29,38].…”