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Article

OnabotulinumtoxinA Is an Effective Treatment for Reducing the Interictal Burden in Patients with Chronic Migraine: A Prospective Observational Study

by
Alejandro Sánchez-Huertas
1,
Oscar Camejo-Mas
1,
Sebastian Garcia-Roldan
1,
Rocio Alonso-Castillo
1,
Lara Pulido-Fraiz
1,
Andrea Higuera Ruiz de la Hermosa
1,
Leonardo Portocarrero-Sánchez
1 and
Javier Díaz-de-Terán
1,2,*
1
Neurology Department, Hospital Universitario La Paz, 28046 Madrid, Spain
2
Hospital La Paz Institute for Health Research (IdiPAZ), Hospital Universitario La Paz, University Autónoma de Madrid, 28046 Madrid, Spain
*
Author to whom correspondence should be addressed.
Toxins 2025, 17(9), 463; https://doi.org/10.3390/toxins17090463
Submission received: 18 July 2025 / Revised: 26 August 2025 / Accepted: 8 September 2025 / Published: 16 September 2025
(This article belongs to the Special Issue Botulinum Neurotoxins for the Treatment of Chronic Pain and Headaches)

Abstract

Interictal burden (IB), defined as the symptoms and impairments that occur between migraine attacks, including cognitive dysfunction, photophobia, and fatigue, is recognized as a significant determinant of quality of life in patients. A prospective observational study was conducted. Patients diagnosed with chronic migraine (CM) and under treatment with OnabotulinumtoxinA (OnabotA) according to the PREEMPT protocol (every 12 weeks) were assessed at baseline and at 3, 6, 9, and 12 months. The primary endpoint was to evaluate the change in the IB measured with the Migraine Interictal Burden Scale (MIBS-4) and in the monthly migraine days (MMD). The secondary endpoint was acute medication use. This single-center study included 150 patients (91.3% female; median age 44 years). MIBS-4 scores were decreased by 29.1% at 3 months (8.47 to 5.97) and by 41.6% at 12 months (to 4.86; p < 0.001). IB-free status was achieved by 16 patients (10.7%). The most disabling baseline symptoms were photophobia (37%), fatigue (20%), and allodynia (18%), which reduced by 52%, 43%, and 39% at 12 months, respectively. MMD were reduced from 18.6 to 8.3 days at 12 months and triptan and analgesic intake decreased by 58.7% and 55.4%. OnabotA significantly reduced both IB and migraine frequency over 12 months, underscoring its relevance in CM management.
Keywords: migraine; chronic migraine; OnabotulinumtoxinA; interictal burden; interictal symptoms; quality of life migraine; chronic migraine; OnabotulinumtoxinA; interictal burden; interictal symptoms; quality of life

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MDPI and ACS Style

Sánchez-Huertas, A.; Camejo-Mas, O.; Garcia-Roldan, S.; Alonso-Castillo, R.; Pulido-Fraiz, L.; Higuera Ruiz de la Hermosa, A.; Portocarrero-Sánchez, L.; Díaz-de-Terán, J. OnabotulinumtoxinA Is an Effective Treatment for Reducing the Interictal Burden in Patients with Chronic Migraine: A Prospective Observational Study. Toxins 2025, 17, 463. https://doi.org/10.3390/toxins17090463

AMA Style

Sánchez-Huertas A, Camejo-Mas O, Garcia-Roldan S, Alonso-Castillo R, Pulido-Fraiz L, Higuera Ruiz de la Hermosa A, Portocarrero-Sánchez L, Díaz-de-Terán J. OnabotulinumtoxinA Is an Effective Treatment for Reducing the Interictal Burden in Patients with Chronic Migraine: A Prospective Observational Study. Toxins. 2025; 17(9):463. https://doi.org/10.3390/toxins17090463

Chicago/Turabian Style

Sánchez-Huertas, Alejandro, Oscar Camejo-Mas, Sebastian Garcia-Roldan, Rocio Alonso-Castillo, Lara Pulido-Fraiz, Andrea Higuera Ruiz de la Hermosa, Leonardo Portocarrero-Sánchez, and Javier Díaz-de-Terán. 2025. "OnabotulinumtoxinA Is an Effective Treatment for Reducing the Interictal Burden in Patients with Chronic Migraine: A Prospective Observational Study" Toxins 17, no. 9: 463. https://doi.org/10.3390/toxins17090463

APA Style

Sánchez-Huertas, A., Camejo-Mas, O., Garcia-Roldan, S., Alonso-Castillo, R., Pulido-Fraiz, L., Higuera Ruiz de la Hermosa, A., Portocarrero-Sánchez, L., & Díaz-de-Terán, J. (2025). OnabotulinumtoxinA Is an Effective Treatment for Reducing the Interictal Burden in Patients with Chronic Migraine: A Prospective Observational Study. Toxins, 17(9), 463. https://doi.org/10.3390/toxins17090463

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