Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe

Objective To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. Background Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-world data are limited. Design/methods A prospective, observational, post-authorization study in adult patients with chronic migraine treated with onabotulinumtoxinA. Data were collected at the first study injection and approximately every three months for 52 weeks for utilization and 64 weeks for safety data, and summarized using descriptive statistics. Results Eighty-five physicians (81% neurologists) at 58 practices in the United Kingdom, Germany, Spain, and Sweden participated and recruited 1160 patients (84.2% female, median age 46.6 years). At baseline, 85.8% of patients had physician diagnoses of chronic migraine/transformed migraine and reported an average of 11.3 (SD=6.9) severe headache days per 28 days;50.6% had previously used onabotulinumtoxinA for chronic migraine. A total of 4017 study treatments were observed. The median number of injection sites (n=31) and total dose (155 U) were consistent across all treatment sessions, with a median 13.7 weeks observed between sessions. At least one treatment-related adverse event was reported by 291 patients (25.1%);the most frequently reported treatment-related adverse event was neck pain (4.4%). Most patients (74.4%) were satisfied/extremely satisfied with onabotulinumtoxinA treatment. Conclusions Patient demographics/characteristics are consistent with published data on the chronic migraine population. Utilization of onabotulinumtoxinA treatment for chronic migraine appears to be consistent with the Summary of Product Characteristics and published PREEMPT injection paradigm. No new safety signals were identified

Observations at the CNS-PNS border of ventral roots connected to a neuroma

Previous studies have shown that numerous sprouts originating from a neuroma, after nerve injury in neonatal animals, can invade spinal nerve roots. In this study the border between the central and peripheral nervous system (CNS-PNS border) of ventral roots in kittens was examined with both light and electron microscopy after early postnatal sciatic nerve resection. A transient ingrowth of substance P positive axons was observed into the CNS, but no spouts remained 6 weeks after the injury. Using serial sections and electron microscopy it was possible to identify small bundles of unmyelinated axons that penetrated from the root fascicles for a short distance into the CNS. These axons ended blindly, sometimes with a growth cone-like terminal swelling filled with vesicles. The axon bundles were accompanied by p75 positive cells in both the root fascicles and the pia mater, but not in the CNS. It may thus be suggested that neurotrophin presenting p75 positive cells could facilitate axonal growth into the pia mater and that the lack of such cells in the CNS compartment might contribute to the failure of growth into the CNS. A maldevelopment of myelin sheaths at the CNS-PNS border of motor axons was observed and it seems possible that this could have consequences for the propagation of action potential across this region after neonatal nerve injury

Infectious and inflammatory disorders might increase the risk of developing idiopathic intracranial hypertension – a national case-control study

10.1177/0333102420928079Cephalalgia033310242092807-03331024209280

A pilot study of the feasibility of a Swedish multimodal group intervention for severe migraine - The migraine patient school

Objectives: To evaluate a multidisciplinary group intervention, the migraine patient school (MPS), for patients with severe, mostly chronic migraine. Method: A 13-week group intervention program including seven sessions of patient education, practical body awareness and relaxation exercises, and home assignments was performed in small groups with 5–11 participants. Four groups were consecutively included from spring 2014 to fall 2015. Headache diaries and standardized and study-specific questionnaires were used for evaluation at baseline before MPS (pre-interventional phase), and at follow-up. Results: Twenty-four of 30 included patients completed the study, i.e. attended ≥ four sessions. Most participants found it rewarding to participate in the MPS and easy to take part in, understand and complete home assignments. Validated standardized questionnaires delivered before, and after (follow-up) MPS showed that the impact on life (HIT-6) and avoidance behavior (PIPS-A) were significantly improved whereas quality of life (MSQL), anxiety and depression (HAD) and perceived stress (PSS-14) did not show a statistically significant change. Conclusion: The Migraine patient school with a multimodal educational and behavioral group intervention program was feasible to perform and seem to benefit patients with severe (high-frequency or chronic) migraine. © The Author(s) 2021