Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study

Blumenfeld, Andrew; Stark, Richard; Freeman, Marshall C.; Orejudos, Amelia; Adams, Aubrey Manack

doi:10.1186/s10194-018-0840-8

Cited by 151 publications

(205 citation statements)

References 29 publications

Supporting

Mentioning

160

Contrasting

Unclassified

Order By: Relevance

“…In adults, it has been established in the pooled PREEMPT studies that a meaningful proportion of patients who failed to respond to the first treatment became responders after additional treatment cycles . In addition, the results of the long‐term, open‐label COMPEL study showed that the mean reduction in the number of headache days per 28 days was greater after 9 treatment cycles (108 weeks; −10.7 headaches) than after 2 treatment cycles (24 weeks; −7.4 headaches) . Therefore, a longer study to explore the safety and efficacy of repeated exposure to onabotulinumtoxinA in the developing adolescent, with at least 2 treatment cycles, may be necessary in this population to detect significant differences between onabotulinumtoxinA and placebo treatment.…”

Section: Discussionmentioning

confidence: 99%

“…The findings also offer insights on study design that can be used to guide future research into the efficacy of onabotulinumtoxinA for the prevention of migraine in adolescents with CM. In adults, the beneficial effects of onabotulinumtoxinA have been shown to increase with multiple treatments . Therefore, to fully assess the benefits of treatment in adolescents, we suggest that future pediatric trials evaluate at least 2 treatment cycles of onabotulinumtoxinA, enroll larger numbers of patients, and explore the use of a placebo run‐in or crossover design.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A Randomized Trial to Evaluate OnabotulinumtoxinA for Prevention of Headaches in Adolescents With Chronic Migraine

et al. 2020

View full text Add to dashboard Cite

Objective As a post‐approval commitment, this dose‐ranging study was undertaken to evaluate efficacy and safety of onabotulinumtoxinA in adolescents. Background In adolescents, migraine is often undiagnosed or misdiagnosed and can present unique management challenges. OnabotulinumtoxinA was approved for prevention of chronic migraine (CM) in adults in 2010. Methods This multicenter, double‐blind, parallel‐group, randomized trial assessed a single treatment of onabotulinumtoxinA (155 U or 74 U) vs placebo (intramuscular saline) administered via the recommended fixed‐dose fixed site paradigm in adolescents with CM aged 12 to <18 years. The primary efficacy measure was change in frequency of headache days from baseline at week 12; other measures included change in frequency of headache days at weeks 4 and 8 and change in frequency of severe headache days. Safety and tolerability were assessed. Results Of 125 randomized patients (onabotulinumtoxinA 155 U, n = 45; onabotulinumtoxinA 74 U, n = 43; placebo, n = 37), all were included in the primary efficacy analysis, and 115 (92.0%) completed the study. Lack of efficacy was the primary reason for discontinuing (n = 4; 3.2%); no patients discontinued because of adverse events. All treatments reduced frequency of headache days at week 12, with no significant differences between treatments. The mean (95% confidence interval) changes from baseline in the frequency of headache days during the 28‐day period ending at week 12 (primary endpoint) were −6.3 (−8.5, −4.2), −6.4 (−8.8, −4.0), and −6.8 (−9.6, −4.1) days in the onabotulinumtoxinA 155 U, onabotulinumtoxinA 74 U, and placebo groups, respectively (P ≥ .474). All treatments reduced frequency of severe headache days and were well‐tolerated; serious adverse events (n = 3) were considered unrelated to treatment and resolved without sequelae. The most commonly reported treatment‐emergent adverse events were neck pain (n = 8), upper respiratory tract infection (n = 7), migraine, and nasopharyngitis (n = 5 each). Conclusion Although this study did not meet its efficacy endpoints, onabotulinumtoxinA was well tolerated in this adolescent population. Given previous data demonstrating the benefits of onabotulinumtoxinA in adults with CM, additional studies with design modifications, including adequate statistical power, to assess the efficacy of multiple treatment cycles of onabotulinumtoxinA for CM prevention in adolescents may be informative.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Randomized Trial to Evaluate OnabotulinumtoxinA for Prevention of Headaches in Adolescents With Chronic Migraine

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Since PREEMPT regulatory trials were done, several open‐label and real‐life pragmatic studies have already demonstrated the effectiveness of onabotulinumtoxinA in terms of frequency and analgesic intake as main end‐points but also in improving headache intensity and quality of life .…”

Section: Discussionmentioning

confidence: 99%

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

View full text Add to dashboard Cite

Background and purpose The aim was to analyse the clinical characteristics of a long‐term follow‐up of patients with chronic and high‐frequency episodic migraine in treatment with onabotulinumtoxinA. Methods Patients diagnosed with high‐frequency episodic migraine (HFEM) or chronic migraine (CM) according to the International Classification of Headache Disorders 3 beta were included. A comparative analysis was carried out at each study time point identifying outcome measures according to initial diagnosis and treatment duration. Results In all, 578 patients were recruited and after 24 months outcome data were collected from 100 patients: 84.0% CM and 16.0% HFEM. After 24 months, headache frequency was significantly reduced by 10.5 days from baseline, 64.0% reported a ≥50% reduction in pain intensity and 70.0% of patients had ≥50% reduction in analgesic use. Comparing baseline diagnoses, at month 6 CM patients presented higher mean reduction in frequency (CM 44.3% ± 32.6% vs. HFEM 34.6% ± 24.8%) and analgesic use (CM 53.6% ± 35.4% vs. HFEM 39.3% ± 33.2%). At month 12, the mean reduction in frequency was similar in CM and HFEM patients (CM 44.7% ± 33.4% vs. HFEM 41.2% ± 28.2%). Improvement in pain intensity, analgesic use and Migraine Disability Assessment were proportional in both diagnoses. Conclusions OnabotulinumtoxinA efficacy is significant at 6 months in frequency and analgesic intake and remains stable during follow‐up, whilst the intensity of pain decreases in a stepwise manner at each time point of the analysis. The improvement in CM and HFEM patients is proportional and significant after 1 year of treatment.

show abstract

“…11,12 Its mechanism of action may include blocking the release of inflammatory neuropeptides from stimulated sensory neurons including substance P and calcitonin gene-related peptide (CGRP) 13 and may decrease the promotion of central sensitization. 15,16 Patients with chronic migraine who do not respond to the first treatment cycle of onabotA are recommended to try at least 2 or 3 treatments before the determination of efficacy. 15,16 Patients with chronic migraine who do not respond to the first treatment cycle of onabotA are recommended to try at least 2 or 3 treatments before the determination of efficacy.…”

Section: Introductionmentioning

confidence: 99%

OnabotulinumtoxinA Wear‐off Phenomenon in the Treatment of Chronic Migraine

Masters-Israilov

Robbins

2019

Headache

View full text Add to dashboard Cite

Objective To evaluate the frequency and features of onabotulinumtoxinA (onabotA) wear‐off in chronic migraine (CM). Background Clinical experience suggests that patients with CM frequently perceive onabotA treatment duration <12 weeks, but this phenomenon has not been well explored. Methods This study was a retrospective chart review of patients (n = 143) with CM initiated on onabotA over a 2‐year period. Wear‐off was considered present with the phrase documented, a quantitative headache day increase, or increased use of abortive medications, bridging therapies or emergency department visits in the 6 weeks preceding the subsequent administration. Results Wear‐off was present in 90/143 patients (62.9%). Age, sex, medication overuse, psychiatric comorbidity, injector training level, and mean days between injections did not differ between the wear‐off and no wear‐off groups. Mean units injected per session in the wear‐off group until first documented wear‐off were significantly less vs no wear‐off group (166.0 ± 13.1 vs 173.4 ± 10.3, P = .0005). Wear‐off most commonly occurred 2‐4 weeks before the next injection (43.3%) and after the very first injection (40.0%). Intramuscular ketorolac injections (33.3%) and peripheral nerve blocks (25.6%) were the most common bridge therapies used in the wear‐off period. Conclusions Most patients with CM receiving onabotA experience wear‐off. Clinicians may consider increasing the units used from the treatment onset to reduce the frequent need for bridging therapies.

show abstract

Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study

Cited by 151 publications

References 29 publications

A Randomized Trial to Evaluate OnabotulinumtoxinA for Prevention of Headaches in Adolescents With Chronic Migraine

A Randomized Trial to Evaluate OnabotulinumtoxinA for Prevention of Headaches in Adolescents With Chronic Migraine

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

OnabotulinumtoxinA Wear‐off Phenomenon in the Treatment of Chronic Migraine

Contact Info

Product

Resources

About