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A Double‐Blind Comparison of OnabotulinumtoxinA (BOTOX ® ) and Topiramate (TOPAMAX ® ) for the Prophylactic Treatment of Chronic Migraine: A Pilot Study
Abstract
Background.— There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective.— To compare the efficacy and safety of onabotulinumtoxinA (BOTOX ® , Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX ® , Ortho‐McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods.— In this single‐center, double‐blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed‐site and 100 U follow‐the‐pain), plus an oral placebo, or topiramate, 4‐week titration to 100 mg/day with option for additional 4‐week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9‐point scale (+4 = clearance of signs and symptoms and −4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT‐6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4‐week screening period and a 2‐week optional final safety visit. Follow‐up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results.— Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment‐related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between‐group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi‐square). In both groups, HA/migraine days decreased and MIDAS and HIT‐6 scores improved. Patient‐reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ≥50% reduction in HA/migraine days. Forty‐one treatment‐related AEs were reported in 18 onabotulinumtoxinA‐treated patients vs 87 in 25 topiramate‐treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions.— OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations.
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“significant issues persist in patients who do not benefit from current drug treatments [54, 55]”
From Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial. (2018) · cites this paper as [55]
Citations
Cites
Goadsby, P. J. (2004) · Cephalalgia · doi:10.1111/j.1468-2982.2004.00711.x · Cited by 2,381
Migraine prevalence, disease burden, and the need for preventive therapy
Lipton, R. B., Bigal, M. E., Diamond, M., Freitag, F., Reed, M. L., & Stewart, W. F. (2007) · Neurology · doi:10.1212/01.wnl.0000252808.97649.21 · Cited by 2,337
Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II
Lipton, R. B., Stewart, W. F., Diamond, S., Diamond, M. L., & Reed, M. (2001) · Headache: The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.2001.041007646.x · Cited by 2,268
New Appendix Criteria Open for a Broader Concept of Chronic Migraine
Olesen, J., Bousser, M.-G., Diener, H.-C., Dodick, D., First, M., Goadsby, P., Göbel, H., Lainez, M., Lance, J., Lipton, R., et al. (2006) · Cephalalgia · doi:10.1111/j.1468-2982.2006.01172.x · Cited by 909
DOUBLE-BLIND STUDY OF BOTULINUM TOXIN IN SPASMODIC TORTICOLLIS
Tsui, J. K. C., Stoessl, A. J., Eisen, A., Calne, S. M., & Calne, D. B. (1986) · The Lancet · doi:10.1016/s0140-6736(86)92070-2 · Cited by 804
Subcutaneous administration of botulinum toxin A reduces formalin-induced pain
Cui, M., Khanijou, S., Rubino, J., & Aoki, K. R. (2003) · Pain · doi:10.1016/j.pain.2003.10.008 · Cited by 675
Topiramate for Migraine Prevention A Randomized Controlled Trial
Brandes, J. L. (2004) · JAMA · doi:10.1001/jama.291.8.965 · Cited by 653
Diener, H., Bussone, G., Oene, J. V., Lahaye, M., Schwalen, S., & Goadsby, P. (2007) · Cephalalgia · doi:10.1111/j.1468-2982.2007.01326.x · Cited by 561
Botulinum Toxin Type A as a Migraine Preventive Treatment
Silberstein, S. D., Mathew, N. T., Saper, J. R., & JENKINS, S. W. (2000) · Headache The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.2000.00066.x · Cited by 539
Self-citationTopiramate in Migraine Prevention
Silberstein, S. D. (2004) · Archives of Neurology · doi:10.1001/archneur.61.4.490 · Cited by 533
Research works printed but not linked: 2
- Mathew NT, 2003, Topiramate in migraine prevention (MIGR‐001): Effect on migraine frequency, Neurology, 60
- The International Classification of Headache Disorders, 2004, Headache Classification Subcommittee of the International Headache Society, Cephalalgia, 24, 1
Cited by
Sorted by citations
Items 101–152 of 152
Corbelli, I., Verzina, A., Magistris, I. L. D., Vanna, G. D., Eusebi, P., Mataluni, G., Pisani, A., Prudenzano, M. P., Trojano, M., Delussi, M. D., et al. (2022) · Toxins · doi:10.3390/toxins15010034 · Cited by 7
“9%), which have often led to the abandonment of this latter drug [9,10,24].”
BackgroundMimeh, H., Magrin, A. M. F., Myers, S. R., & Ghanem, A. M. (2018) · Aesthetic Surgery Journal · doi:10.1093/asj/sjy224 · Cited by 7
Onan, D., Bentivegna, E., & Martelletti, P. (2022) · Toxins · doi:10.3390/toxins15010029 · Cited by 10
Botulinum toxin in headache treatment: Finally a promising path?
Schoenen, J. E. (2010) · Cephalalgia · doi:10.1177/0333102410373154 · Cited by 7
“Onabotulinum toxin A was directly compared to topiramate in a small randomized double-blind singlecentre trial (8).”
MethodImpact of Amitryptiline on Migraine Disability Assessment Score
Moras, K. (2014) · JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH · doi:10.7860/jcdr/2014/7546.4854 · Cited by 6
Beckmann, Y. Y., Üncü, F. Ç., İncesu, T. K., & Türe, S. (2020) · European Neurology · doi:10.1159/000509853 · Cited by 6
Botulinum toxin for the treatment of headache: a promising path on a "dead end road"?
Delstanche, S., & Schoenen, J. E. (2010) · PubMed · Cited by 6
OnabotulinumtoxinA for Chronic Migraine
Blumenfeld, A. M., & Evans, R. W. (2012) · Headache The Journal of Head and Face Pain · doi:10.1111/j.1526-4610.2011.02081.x · Cited by 6
“1% for topiramate).(11) The results from the second trial of 59 chronic migraine patients(12) were comparable with the first trial.”
ResultEmerging Therapies for Chronic Migraine
Cecchini, A. P., & Grazzi, L. (2014) · Current Pain and Headache Reports · doi:10.1007/s11916-014-0408-5 · Cited by 6
Recently approved and emerging drug options for migraine prophylaxis
Bentivegna, E., Luciani, M., Ferrari, V., Galastri, S., Baldari, F., Scarso, F., Lamberti, P. A., & Martelletti, P. (2022) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2022.2102420 · Cited by 5
“Moreover, experts suggest that patients should fail at least two or three prophylactic drugs before starting OBTA treatment [67], which has shown an excellent tolerability compared to oral prophylactic therapy [68].”
BackgroundGonzález‐Quintanilla, V., Evers, S., & Pascual, J. (2024) · Handbook of clinical neurology · doi:10.1016/b978-0-12-823357-3.00007-0 · Cited by 5
CONSORT recommendations in abstracts of randomised, controlled trials on migraine and headache
Tfelt‐Hansen, P. C. (2011) · The Journal of Headache and Pain · doi:10.1007/s10194-011-0361-1 · Cited by 5
“[23] 19/17 ? ? -”
BackgroundJost, W. H. (2011) · The Open Pain Journal · doi:10.2174/1876386301104010004 · Cited by 5
OnabotulinumtoxinA: Preventive Treatment for Chronic Migraine
Chen, S., Fuh, J., & Wang, S. (2010) · Current Pain and Headache Reports · doi:10.1007/s11916-010-0150-6 · Cited by 5
“Two randomized controlled studies conducted in the United States and Europe, respectively, demonstrated that topiramate is effective as headache prophylaxis in CM [10, 11].”
BackgroundOnabotulinumtoxin A en el tratamiento de la migraña crónica
Andrés, J. M. L. (2012) · Revista de Neurología · doi:10.33588/rn.54s02.2012112 · Cited by 5
Botulinum toxin for migraine treatment
Summ, O., Evers, S., & Husstedt, I. W. (2013) · doi:10.2217/ebo.12.230 · Cited by 5
Kronik Migrenin Aydınlanmaya Başlayan Yüzü
Özemir, Z. A., & Baykan, B. B. (2013) · Nöro Psikiyatri Arşivi · doi:10.4274/npa.y7244 · Cited by 5
“In the PREEMPT study in which the efficiency of BTX in CM was shown, onabotulinumtoxin A or placebo was administered to 679 and 705 patients every 12 weeks for 32 weeks.”
InfluentialDiener, H., Holle, D., Muller, D. W., Nägel, S., & Rabe, K. (2013) · Der Nervenarzt · doi:10.1007/s00115-012-3625-3 · Cited by 4
Chronic migraine - new treatment options.
Roceanu, A. M., Antochi, F. A., & Băjenaru, O. (2014) · Europe PMC (PubMed Central) · Cited by 4
Effectiveness and Tolerability of Pharmacologic Prophylaxis for Chronic Migraine
Khalili, M., Haghdoost, F., Liaghatdar, A., Torabiardakani, K., Mahdian, F., Levit, T., Moradi, S., Hedayati, E., Ahmadi, F., Khademioore, S., et al. (2026) · Annals of Internal Medicine · doi:10.7326/annals-25-02221 · Cited by 3
Comprehensive management of adults with chronic migraine: Clinical practice guidelines in Mexico
Vélez-Jiménez, M.-K., Chiquete-Anaya, E., Orta, D. S. J., Villarreal-Careaga, J., Amaya-Sánchez, L. E., Collado-Ortiz, M. Á., Diaz-García, M. L., Gudiño-Castelazo, M., Hernández-Aguilar, J., Juárez-Jiménez, H., et al. (2021) · Cephalalgia Reports · doi:10.1177/25158163211033969 · Cited by 4
Migraine : données épidémiologiques, cliniques et thérapeutiques
Roos, C. (2019) · Biologie Aujourd hui · doi:10.1051/jbio/2019019 · Cited by 3
Recomendações Terapêuticas para Cefaleias da Sociedade Portuguesa de Cefaleias – 2021
Parreira, E. (2021) · Sinapse · doi:10.46531/sinapse/gu/200048/2021 · Cited by 3
Lyseng-Williamson, K. A., & Frampton, J. E. (2012) · CNS Drugs · doi:10.2165/11208930-000000000-00000 · Cited by 3
“In two small (n£ 60) trials,([24,25]) both treatments had similar effectiveness in preventing chronicmigraine (61–83% of patients in the onaBoNTA and topiramate arms responded to treatment).”
Royle, P., Cummins, E., Walker, C., Chong, S., Kandala, N., & Waugh, N. R. (2011) · Cited by 3
Moreno‐Ajona, D., Martínez, M. D. V., Chan, C., & Goadsby, P. J. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-820472-6.00083-9 · Cited by 2
The Burden of Migraine in Real Clinical Practice: Clinical and Economic Aspects
Наприенко, М. В., Smekalkina, L. V., Сафонов, М. И., Filatova, E. G., Владимировна, Л. Н., Ekusheva, E. V., Artemenko, A. R., Osipova, V. В., & Baiushkina, L. I. (2019) · Neuroscience and Behavioral Physiology · doi:10.1007/s11055-019-00862-5 · Cited by 2
Pharmacological Management of Migraine Headaches
Moloney, M. F., & Cranwell-Bruce, L. A. (2010) · The Nurse Practitioner · doi:10.1097/01.npr.0000387140.64670.2e · Cited by 2
Novel Approaches in Migraine Treatment
Diener, H. (2013) · doi:10.2217/9781780842349 · Cited by 2
Medical Interventions for Migraine That Has Become Difficult to Treat
Martelletti, P., & Negro, A. (2011) · Springer eBooks · doi:10.1007/978-88-470-1700-9_32 · Cited by 1
OnabotulinumtoxinA in the treatment of migraine headache
Dougherty, C. O., & Silberstein, S. D. (2012) · Techniques in Regional Anesthesia and Pain Management · doi:10.1053/j.trap.2012.11.006 · Cited by 1
“At the 9 month endpoint, a similar number of patients reported a ≥50% decrease in headache/migraines days in the BoNT-A and topiramate groups, 40.9% and 42.9% respectively 33 .”
InfluentialAn emerging problem in clinical practice: how to treat chronic headache patients
Pini, L. A. (2010) · Internal and Emergency Medicine · doi:10.1007/s11739-010-0484-4 · Cited by 1
“In fact, adverse events due to topiramate therapy result more often in abandoning the treatment itself [1, 7, 8].”
BackgroundAzadvari, M., Hosseini, M., Razavi, S. Z. E., Ghajarzadeh, M., & Vaheb, S. (2023) · Annals of Military and Health Sciences Research · doi:10.5812/amh-139223 · Cited by 1
Antiplatelet therapy in women with acute coronary syndrome.
Foody, J. M. (2014) · PubMed · Cited by 1
Comprehensive review and update on chronic migraine
Moon, H. (2018) · Journal of Korean Medical Association · doi:10.5124/jkma.2018.61.5.314 · Cited by 1
“보툴리눔독소 A형 외 의 약제로는 토피라메이트(topiramate)와 아미트립틸린 (amitriptyline)이 만성편두통예방치료에 있어서 보툴리 눔독소 A형과 대등한 효과가 입증되었다[17-19].”
Zheng, H., Huang, S., Chen, Y.-Y., Tang, T., Qin, D., & Chen, M. (2020) · Research Square · doi:10.21203/rs.3.rs-56656/v1 · Cited by 1
Smith, H. S., Pappagallo, M., & Stahl, S. M. (2012) · Cambridge University Press eBooks · doi:10.1017/cbo9781139194464.008
Botulinum Toxin in the Management of Painful Conditions
Gerwin, R. D. (2012) · Springer eBooks · doi:10.1007/978-1-4614-1560-2_54
“The authors themselves refer to a pilot study comparing onabotulinumtoxinA to topiramate [ 34 ], an FDA-approved drug for the prevention of migraine.”
BackgroundDodick, D. W., Turkel, C. C., DeGryse, R. E., Aurora, S. K., Silberstein, S. D., Lipton, R. B., Diener, H., & Brin, M. F. (2010)
Cady, R. K. (2014) · PubMed
Bártková, A. (2017) · Neurologie pro praxi · doi:10.36290/neu.2017.130
Botulinum Toxin Treatment of Migraine and Other Headaches
Schaefer, S. M., & Jabbari, B. (2017) · Springer eBooks · doi:10.1007/978-3-319-56038-0_9
The Future of Migraine Prevention
Cowan, R. P. (2018) · Headache The Journal of Head and Face Pain · doi:10.1111/head.13418
“Matthew and Jafri compared onabotulinumtoxinA and topiramate in 2009, which showed better tolerability, which is an important element in adherence, but this was a 3-moth study prior to PREEMPT.7 A more recent review from Tassorelli et al looked at longer-term management of chronic migraine in level 3 headache centers…”
BackgroundSilberstein, S. D., & Marmura, M. J. (2010) · doi:10.1017/cbo9780511841392.013
(2011) · Current Opinion in Neurology · doi:10.1097/wco.0b013e328347b40e
Obelienienė, D., Pėstininkaitė, R., & Rastenytė, D. (2020) · IntechOpen eBooks · doi:10.5772/intechopen.93314
Botulinum Toxin in the Management of Painful Conditions
Gerwin, R. D. (2014) · Springer eBooks · doi:10.1007/978-1-4939-1824-9_35
Totonchi, A. S., DeLeonibus, A., & Guyuron, B. (2024) · Springer eBooks · doi:10.1007/978-3-031-48503-9_48
Delivery of antimigraine drugs to the brain through novel drug delivery systems
Pandey, M., Mayuren, J., Pooja, P., Sharma, D., Kumar, T., Nirban, S., Butt, A. M., Jain, N., & Gorain, B. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-13474-6.00032-9
Beddingfield, K. A. (2013) · Digital Commons - PCOM (Philadelphia College of Osteopathic Medicine)
OnabotulinumtoxinA en la migraña crónica: de la teoría de los ensayos clínicos a la práctica clínica
Muiño, R. L. (2014) · Revista de Neurología · doi:10.33588/rn.58s02.2014098
“En el primero de ellos, un estudio piloto realizado por Mathew y Jaffri [12], ambos fármacos mostraron la misma eficacia en el tratamiento preventivo de la migraña crónica, si bien en el grupo de la OnabotA se refirieron menos efectos adversos y se produjeron menos abandonos.”
BackgroundNaya, M. G., Hernando-Quintana, N., Jiménez, A. M. L., Gómez, C. R., Roy, J. A., Gomara, M. J. G., Lasaosa, S. S., Valiente, S. S., & Llerda, J. Á. M. (2014) · Revista de Neurología · doi:10.33588/rn.5909.2014400
“De ahí que cada vez su utilización vaya en aumento, sobre todo en aquellos pacientes que no han respondido a los tratamientos preventivos orales convencionales o que presentan problemas de intolerancia a dichos fármacos [20-23].”
Background
Metadata
- Authors
- Mathew, N. T., & Jaffri, S. F. A.
- Affiliations
- Houston Headache & Neurological Institute (US)
- Venue
- Headache: The Journal of Head and Face Pain
- Publisher
- Wiley
- Published
- 2009-11
- Volume
- 49
- Issue
- 10
- Pages
- 1466-1478
- ISSN
- 0017-8748 (ISSN-L)
- 1526-4610
- OpenAlex
- W2084866959
- Cited by
- 153
- References
- 38
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 6 · 2023: 5 · 2022: 5 · 2021: 11 · 2020: 8 · 2019: 15 · 2018: 8 · 2017: 9 · 2016: 3 · 2015: 11 · 2014: 14 · 2013: 11 · 2012: 16
- FWCI
- 9.25
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Headache The Journal of Head and Face Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Migraine and Headache Studies
- Health Sciences › Dentistry › Oral Surgery › Temporomandibular Joint Disorders
- Health Sciences › Medicine › Clinical Neurology › Botulinum Toxin and Related Neurological Disorders
- Keywords
- chronic migraine, migraine prophylaxis, onabotulinumtoxinA, topiramate, botulinum toxin, antiepileptic drugs, headache days, migraine disability, Headache Impact Test, Migraine Disability Assessment, adverse events, drug safety, treatment discontinuation
- MeSH terms
- Topiramate, Adult, Chronic Disease, Double-Blind Method, Female, Fructose, Humans, Male, Middle Aged, Migraine Disorders, Pilot Projects, Prospective Studies, Treatment Outcome, Botulinum Toxins, Type A
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