OnabotulinumtoxinA in the treatment of refractory chronic cluster headache

Abstract

BackgroundCluster headache (CH) is a clinically well-defined primary headache disorder, approximately 20% of cluster headache sufferers experience recurrent attacks without periods of significant remission. For the treatment of chronic cluster headache (CCH) only limited therapeutic options are available.MethodsA potential refractory CCH patient group was identified according to the clinical definition of rCCH based on the consensus statement of the European Headache Federation (EHF). Treatment with OnabotulinumtoxinA (BoNT-A; Botox®, 150 Allergan IU) was done according to the PREEMPT study protocol. A standardized headache diary was used for recording frequency, duration of attacks and pain intensity. To assess personal burden the HIT-6 and the Hospital Anxiety and Depression scale was used. Primary outcome measure was a > 50% reduction in headache minutes.ResultsSeventeen male patients suffering from rCCH, aged 32 ± 11 (mean ± SD) years, presenting a mean disease duration of 6.6 years completed the study of 28 weeks. The cut-off point of > 50% reduction in headache minutes as positive result was reached in 58.8%, 29.4% experienced an improvement of 30–50%. Mean frequency of headache days dropped from 28.2 to 11.8 days at week 24 (p = 0.0001; 95% CI -21.33 to − 11.61;). Intensity of remaining attacks was also reduced significantly. Headache disability scores showed a trend to improvement after BoNT-A.ConclusionsEncouraging results for the treatment with BoNT-A in rCCH patients were observed in our study population.

Disability, Quality of Life, and Socioeconomic Burden of Cluster Headache: A Critical Review of Current Evidence and Future Perspectives

“…A summary of these studies and the main findings are reported in Table 3. In 6 of the longitudinal studies on refractory CCH patients 10,11,15,[24][25][26] and in 3 of the cross-sectional studies, 18,27,28 patients completed the Headache Impact Test (HIT-6). The Migraine Disability Assessment (MIDAS) was used in 2 longitudinal 10,11 and 1 cross-sectional study, 18 the Headache Disability Inventory (HDI) was used in 1 cross-sectional study, 29 and the Pain Disability Index (PDI) was used in 1 longitudinal study.…”

Therapeutic strategies that act on the peripheral nervous system in primary headache disorders

“…In this open-label, non-randomized, single-center study, a greater than 50% reduction in headache minutes was reached in 58.8% of the refractory CCH patients. The pain intensity was also significantly reduced in this patient population [142].…”

“…A number of clinical trials using BoNTA-hemagglutinin complex as prophylaxis in CCH patients have been reported [141]; however, only a single trial followed the PREEMPT study protocol until now [142]. In this open-label, non-randomized, single-center study, a greater than 50% reduction in headache minutes was reached in 58.8% of the refractory CCH patients.…”

Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis

“…Real-world data from headache centers in Italy also support the notion that the benefits of onabotulinumtoxinA treatment using the PREEMPT protocol are sustained, even in patients with a recent onset of CM [28]. Preliminary results also suggest that treatment using the PREEMPT protocol may be beneficial to patients with other chronic, difficult-to-treat headache disorders [29].…”