ABSTRACT: Background: PREDICT was a Canadian, multicenter, prospective, observational study in adults naïve to onabotulinumtoxinA treatment for chronic migraine (CM). We descriptively assess health resource utilization, work productivity, and acute medication use. Methods: OnabotulinumtoxinA (155–195 U) was administered every 12 weeks over 2 years (≤7 treatment cycles). Participants completed a 4-item health resource utilization questionnaire and 6-item Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0. Acute medication use was recorded in daily headache diaries. Treatment-emergent adverse events were recorded throughout the study. Results: A total of 197 participants were enrolled, and 184 received ≥1 treatment with onabotulinumtoxinA and were included in the analysis. Between baseline and the final visit, there were decreases in the percentage of participants who reported headache-related healthcare professional visit(s) (96.2% to 76.8%) and those who received headache-related diagnostic testing (37.5% to 9.9%). Reductions from baseline were also observed in the mean number of headache-related visits to an emergency room/urgent care clinic (2.5 to 1.4) and median headache-related hospital admissions (4.0 to 1.0). OnabotulinumtoxinA improved work productivity and reduced the mean (standard deviation) number of hours missed from work over a 7-day period (6.1 [9.7] to 3.0 [6.8]). Mean (standard deviation) acute medication use decreased from baseline (15.2 [7.6] to 9.1 [6.5] days). No new safety signals were identified. Conclusions: Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA treatment for CM in the Canadian population reduces health resource utilization and acute medication use and improves workplace productivity, supporting the long-term benefits of using onabotulinumtoxinA for CM.

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Objectives: Our objectives were 3-fold: Assess the impact of the injection paradigms on muscle function and strength, assess the efficacy and safety over 10 years of repeated treatments every 3 months, identify risk factors maintaining chronicity in this unremitting migraine population. Method: One hundred patients were injected with a Botox dilution ratio of 1:1 with a sterile 0.9 % saline solution, 50 patients with a 100u vial of Botox in one, 1cc tuberculin syringe, and 50 patients with a 200u vial of Botox in two-1cc tuberculin syringe during 10 years. Results: The strength of the paracervical and first portion of the trapezius muscle was altered in 6% (100u) and 18% (155u) of subjects. The strength of the second portion of the trapezius muscle was altered in 2% (100u) and 10% (155u) of subjects. Muscle function of the paracervical and first portion of the trapezius muscles was altered in 34% (100u) and 28% (155) of subjects. For the second portion of the trapezius, muscle 58% (100u) and 52% (155) of subjects. The efficacy of Botox was constantly maintained during the 10 years of treatment. 72% (100u), and 74% (155u) of subjects had less than 7migraine days /month (77% improvement). Early onset of migraine, comorbid emotional burden and chronic neck pain, should be considered as risk factors for the unremitting condition. Conclusion: Muscle strength, and function alteration did not have an impact on esthetics of the face and on normal daily muscle function in both cohorts. In both cohorts, more than 70% of patients had more than 75% improvement in monthly migraine days. Depth of the toxin injection, diffusion and presence of adipose tissue (lean versus obese patients) may be responsible for muscle strength and function alteration.

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Objective To assess the long-term efficacy and safety of erenumab in the subgroup of patients with chronic migraine (CM) in whom prior preventive treatments had failed (TF) (>= 1, >= 2, and >= 3 TF medication categories) and never failed (preventive naive or prior preventive treatments had not failed), using the data from a 52-week, open-label treatment period (OLTP) of the parent study. Background Erenumab is a fully human monoclonal antibody that selectively binds to and inhibits the canonical calcitonin gene-related peptide receptor. There are limited long-term data evaluating the efficacy and safety of erenumab in patients with CM in whom prior preventive treatments had failed. Methods Patients who had completed the 12-week double-blind treatment period (DBTP) in the parent study were eligible to participate in the 52-week OLTP, during which they received erenumab every 4 weeks. The TF subgroups (>= 1, >= 2, and >= 3 TF medication categories) were not mutually exclusive; patients in whom prior preventive treatments from >= 3 medication categories had failed were also counted in the >= 2 and >= 1 medication categories. Endpoints included monthly migraine days (MMD), monthly acute migraine-specific medication days (MSMD), achievement of >= 50%, >= 75%, and 100% reduction from baseline in MMD, and exposure-adjusted patient incidence rates of adverse events (AEs; per 100 patient-years). Results Erenumab treatment provided sustained mean reductions in MMD and MSMD relative to the parent study baseline throughout the 52 weeks of the OLTP across all TF subgroups. At Week 52, the mean MMD change was -8.6 (SD 6.6) (baseline: 18.4 [SD 4.5] days) in the >= 1 TF subgroup. A post hoc completer analysis (52 weeks [OLTP] erenumab) showed that compared with erenumab 70 mg, the 140 mg dose was associated with numerically greater reductions in the mean MMD (Week 40: -8.6 and -7.2 days; Week 52: -9.7 and -7.9 days [>= 1 TF subgroup]) and a higher proportion of patients achieved >= 50%, >= 75%, and 100% response thresholds across all subgroups at Weeks 40 and 52. Overall the exposure-adjusted patient incidence rates of AEs did not increase during the OLTP versus the DBTP (>= 1 TF subgroup: 141.9/100 versus 317.9/100 patient-years), and no new safety signals occurred. Conclusion The long-term treatment with erenumab was well tolerated and showed sustained efficacy in patients with CM in whom prior preventive treatments had failed, with numerically greater treatment effects for 140 mg versus 70 mg.

Objective: PREDICT aimed to assess real-world long-term health-related quality of life (HRQOL) in Canadian patients with chronic migraine (CM) treated with onabotulinumtoxinA. Background: CM can adversely affect HRQOL and daily functioning, resulting in social and economic burden. Design/Methods: Canadian, multicentre, prospective, observational study (NCT02502123) in adults naive to botulinum toxin(s) for CM. OnabotulinumtoxinA was administered ≤7 treatment cycles per the Canadian product monograph. Primary endpoint: mean change in Migraine-Specific Quality of Life (MSQ) at Tx4 vs. baseline. Secondary endpoints: mean change in MSQ at final visit vs. baseline, onabotulinumtoxinA treatment utilization (each session), headache days (daily headache diary), and physician (baseline, Tx4, and final visit)/patient (each session) satisfaction. Unless noted, data presented as mean(SD). Results: 184 participants (average 45 years, predominantly female [84.8%] and Caucasian [94.6%]) received ≥1 treatment with onabotulinumtoxinA. Mean dose of onabotulinumtoxinA per treatment cycle was 171(18) U; treatment interval 13.2(1.8) weeks. At baseline, patients reported 20.9(6.7) headache days/month, which decreased over time (range: −3.5[6.3] at Tx1 to −6.3[7.3] at Tx7; all timepoints versus baseline, p Conclusions: Real-world data from PREDICT demonstrate that onabotulinumtoxinA treatment for CM reduced headache days and improved HRQOL, with high physician and patient satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for CM. Disclosure: Dr. Boudreau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Allergan, Teva, Lilly. Dr. Boudreau has received research support from Lilly.Dr. Finkelstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Teva, Lilly, Aralez, Nuvo. Dr. Graboski has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Aralez, Amgen/Novartis, and Lilly. Dr. Graboski has received research support from Allergan and Amgen/Novartis. Dr. Ong-Lam has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Cannimed and Spectrum Canada. Dr. Christie has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Novartis, Allergan, Teva. Dr. Christie has received research support from Novartis. Dr. Sommer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Sommer holds stock and/or stock options in Katherine Sommer, MRes, PhD, is an employee of Allergan plc and receives stock or stock options. which sponsored research in which Dr. Sommer was involved as an investigator. Dr. Sommer holds stock and/or stock options in Employee of Allergan and receives stock options. Dr. Bhogal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Davidovic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Becker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Weber and Weber.

Objectives: Chronic migraineurs having failed more than 3 preventive drugs were treated with Erenumab alone or as an add on therapy, we assessed the frequency of monthly migraine days, the value of an add on therapy, and all adverse events. Method: After signing an informed consent, patients were clustered in 3 categories. Group I: Erenumab alone. (No botox cohort). Group II: Botulinum Toxin A (Botox), with Erenumab. (Botox cohort). Group III: oral preventive drug with Erenumab. (No Botox cohort).Results: Evaluation was after the 4 th injection session.A total of 158 patients were involved.90 (13%) patients in the Botox cohort.83 (15%) patients in the no Botox cohort.53pts/158 (34%) obtained no improvement, 36pts/158 (23%) obtained a reduction of the intensity only, 69pts/158 (43%) reduced the frequency of their monthly migraine days.57% of patients failed the primary end point.69 patients reduced their migraine frequency: in group I: 16patients (26%), In group II, 45 patients (65%), and group III, 11 patients (15%) reduced their monthly migraine days by 5-7 days.72 adverse events were experienced mostly with the 140 mg dose.The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1%. Conclusion:The add on of Erenumab to a preventive therapy is more effective than Erenumab alone, Botulinum toxin A with Erenumab was the most effective combination.

Objective: To assess long-term health-related quality of life (QoL) in people treated with onabotulinumtoxinA for chronic migraine (CM). Background: CM can impair health-related QoL and daily functioning, resulting in social and economic burden. Design/Methods: Canadian multicentre, prospective, observational study in adults with CM, botulinum toxin naive for migraine (NCT02502123). Based on the Canadian onabotulinumtoxinA product monograph (July 7, 2014), 7 onabotulinumtoxinA treatments were administered post-baseline/screening. This interim analysis includes data from patients who completed 4 treatment sessions (Tx4; ~10 months). Endpoints: Mean change from baseline to Tx4 in Migraine-Specific Quality of Life (MSQ) score (primary); healthcare resource utilization and work productivity (secondary). Results: Patients at baseline (n=196), post-Tx2 (n=173), and post-Tx4 (n=137) received a mean onabotulinumtoxinA dose of 170.4 U (SD=17.2) per session with a mean interval of 13.1 weeks (SD=1.7) between sessions at this interim analysis. OnabotulinumtoxinA treatment significantly (P Conclusions: This interim analysis demonstrated that onabotulinumtoxinA for CM improved health-related QoL and work productivity and reduced healthcare resource utilization. Disclosure: Dr. Boudreau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Lilly, and Teva. Dr. Boudreau has received research support from Allergan, Amgen, Lilly, and Teva. Dr. Becker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen and Novartis. Dr. Becker has received research support from Allergan and Amgen. Dr. Graboski has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Purdue, Lilly, Tribute, Genzyme, Allergan, and Janssen. Dr. Graboski has received research support from Allergan. Dr. Ong-Lam has received research support from Allergan and Lilly. Dr. Finkelstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ian Finkelstein, MD, received grants/honoraria from Allergan, Amgen, Eli Lilly, JJ was a speaker for Allergan, Amgen, Eli Lilly, Teva, and Aralez; and received consulting fees from Allergan, Amgen, Eli Lilly, Tribute, and Novartis. Dr. Christie has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, Lilly, Amgen, Allergan, and Tribute.. Dr. Christie has received research support from Biogen, Novartis, Lilly, Amgen, Allergan, and Tribute. Dr. Bhogal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Davidovic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc.

Subcutaneous erenumab reduced monthly migraine days and increased the likelihood of achieving a ≥ 50% reduction at all monthly assessment points tested in 2 pivotal trials in episodic migraine (EM) and chronic migraine (CM). Early efficacy of migraine preventive medications is an important treatment characteristic to patients. Delays in achievement of efficacy can result in failed adherence. The objective of these post-hoc analyses were to evaluate efficacy in the first 4 weeks after initial subcutaneous administration of erenumab 70 mg, erenumab 140 mg, or placebo.

Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: −2.2 [−4.1, −0.3] for 70 mg and −0.5 [−2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: −2.5 [−3.8, −1.2], for 70 mg and −3.3 [−4.6, −2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: −2.7 [−4.2, −1.2], for 70 mg and −4.3 [−5.8, −2.8] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.

ObjectivesTo compare the impact of a combined nursing and medical approach to a medical follow‐up only on headache outcomes, quality of life, and self‐efficacy in a cohort of migraineurs.BackgroundInterdisciplinary approaches have been proposed for migraine management. A nursing intervention could improve patient outcomes.MethodsWe prospectively studied new patients referred to our tertiary headache center for migraine. The control group was followed by a physician; the active group was also followed by a nurse with a personalized intervention including adaptation of the lifestyle.ResultsTwo hundred patients (176 women and 24 men, mean age 40 years old) were included and classified according to headache frequency. Each group was followed for 12 months with daily headache diaries. One hundred and sixty‐two completed the study. There were no significant differences between groups for the decrease in headache days, the percent of chronic patients reverting to episodic status or the cessation of medication overuse. Patients in the control group were more likely to find a successful prophylaxis (55.6 vs 27.7%, P = .002). Despite this, the mean decrease in HIT‐6 scores at month 8 was 5.23 ± 9.18 for the active group compared with a decrease of 2.10 ± 9.27 for the control group (P = .030, clinically significant difference of 3.13). Headache Management Self‐Efficacy Scale (HMSE) scores, representing the feeling of self‐efficacy, increased by 14.35 ± 18.41 for the active group vs 4.69 ± 21.22 in the control group (P = .002).ConclusionA nursing intervention can lower the impact of migraines on the patient's life. The improvement in the HIT‐6 score in this study was correlated with improvements in self‐efficacy.

Background: Chronic migraine is associated with significant headache-related disability and psychiatric comorbidity. OnabotulinumtoxinA (BOTOX (R)) is effective and well tolerated in the prophylactic treatment of chronic migraine. This study aimed to provide preliminary data on the efficacy and safety of prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depressive symptoms.Methods: This was a prospective, open-label, multicenter pilot study. Eligible patients met International Classification of Headache Disorders 2nd edition Revision criteria for chronic migraine and had associated depressive symptoms, including Patient Health Questionnaire depression module scores of 5-19. Eligible participants received 155 units of onabotulinumtoxinA, according to the PREEMPT protocol, at baseline and week 12. Assessments included headache frequency, the Headache Impact Test T, the Migraine Disability Assessment, the Beck Depression Inventory (R)-II, the nine-item Patient Health Questionnaire depression module, and the seven-item Generalized Anxiety Disorder questionnaire. Adverse events were also monitored.Results: Overall, 32 participants received treatment. At week 24, there were statistically significant mean (standard deviation [SD]) improvements relative to baseline in the number of headache/migraine-free days (+8.2 [5.8]) (P<0.0001) and in the number of headache/migraine days (-8.2 [5.8]) (P<0.0001) per 30-day period. In addition, there were significant improvements in Headache Impact Test scores (-6.3 [6.9]) (P=0.0001) and Migraine Disability Assessment scores (-44.2 [67.5]) (P=0.0058). From baseline to week 24, statistically significant improvements were also seen in Beck Depression Inventory-II (-7.9 [6.0]) (P<0.0001), Patient Health Questionnaire depression module (-4.3 [4.7]) (P<0.0001), and Generalized Anxiety Disorder questionnaire (-3.5 [5.0]) (P=0.0002) scores. No serious adverse events were reported. Adverse events considered related to treatment occurred in 30% of patients and were mild or moderate.Conclusion: Prophylactic onabotulinumtoxinA was well tolerated in patients with chronic migraine and comorbid depression, and was effective in reducing headache frequency, impact, and related disability, which led to statistically significant improvements in depression and anxiety symptoms.

OBJECTIVES:The primary objective was to evaluate the effects of pregabalin relative to placebo in patients with chronic unilateral cervicogenic headache. Primary and secondary end points: To assess the change from baseline in the frequency of cervicogenic headache days per 28-day period between placebo and treatment group. To assess the change from baseline in the intensity of headache, and health outcome measures.STUDY DESIGN:This was a double-blind, randomized, placebo-controlled, parallel-group study, evaluating the efficacy and safety of pregabalin in patients with cervicogenic headache.PROCEDURES:The study consisted of two phases. A baseline of -28 days and a double-blind placebo-controlled phase: with an escalation and maintenance phase, during which patients remained at their highest dose until the end of the study, at Day 86.RESULTS:Forty one patients were randomized, predominantly females, with a mean age of 52 years old. At screening, both groups had, on average, 26 headache-days per month. By the final phase of the study, the number of headache days dropped to 16 per month for the pregabalin group while remaining stable for the placebo group (p=0.037). No serious adverse events were reported during the study.CONCLUSION:In this study, primary objectives were achieved with a statistically significant change of ten days in frequency of headache days; with minor side effects that were well tolerated.