By COLLEEN CREAMER
For VerusMed
When compared with placebo, Allergan Inc.’s Botox (botulinum toxin type A) prophylactic therapy significantly decreases headache impact scores and improves treatment satisfaction measures, but has no effect on pain severity among patients who have been noncompliant with prior preventive medicines, results of a study in the journal Headache show.
The three-month, double-blind study portion was completed by 54 adults with a history of disabling headache who had previously failed prophylaxis treatment for migraine headache because of compliance, tolerability or adherence issues. Patients were randomized to receive placebo or a single set of Botox injections as prophylaxis and were followed for three months by way of biweekly phone calls, participant diary entries and monthly questionnaires.
After this phase, 19 participants who were treated with placebo were offered the option of receiving a single set of Botox injections in a three-month, open-label continuation of the study; 18 of them completed this phase.
On average, the decrease from baseline in the number of headache days and headache episodes per month was significant at month two in subjects receiving Botox but not at months one and three and not in those receiving placebo at any time point. During the open-label phase, the mean decrease from baseline in number of headache days and episodes was significant at months five and six for the Botox arm.
There was no statistically significant difference between the groups in the number of headache days or episodes, although at month two, the difference between the mean decrease in headache episodes per month in subjects receiving Botox compared with placebo approached significance.
Botox had no effect on maximum headache severity when compared with baseline or placebo during the first three months, but relative to baseline, reductions at month one approached significance and at months four and five were significant.
In the Botox group, average scores on the Headache Impact Test-6 significantly fell from baseline every month, and the mean decrease was significantly greater in this arm than in the placebo one at month three. At the same time point, the Botox-treated patients showed significant mean changes on the Migraine Disability Assessment total score relative to baseline and to the placebo-treated subjects.
Finally, the Botox group demonstrated often significant improvements on a majority of treatment satisfaction assessments of the Migraine Impact Questionnaire at months three and six, while the placebo arm never showed improvements.
Most treatment-related adverse events were transient and mild to moderate in severity and caused no study discontinuations.
“[Botox’s] favorable tolerability profile and relatively infrequent dosing regimen, coupled with its beneficial effects on patient disability, migraine impact and quality of life, suggest that it is useful for preventive management of migraine disorder and may be especially helpful for patients that experience or would be predicted to have a issue with compliance, adherence or adverse events,” the authors said.
