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dc.contributor.authorStovner, Lars Jacob
dc.contributor.authorHagen, Knut
dc.contributor.authorTronvik, Erling Andreas
dc.contributor.authorGravdahl, Gøril Bruvik
dc.contributor.authorBurstein, Rami
dc.contributor.authorDodick, David W.
dc.identifier.citationCephalalgia. 2022, 42 (7), 590-597.en_US
dc.description.abstractBackground Anatomical and experimental data indicate that onabotulinimtoxin A could be more efficient and cost-effective for treating chronic migraine with injections targeting the cranial sutures, where collaterals from the meninges penetrate the skull. Methods A new injection paradigm (FollowTheSutures) was tested for safety, tolerability and feasibility in a Phase II, open-label, non-controlled, single-center pilot study. Ninety units of onabotulinimtoxin A (Botox®), were injected in 18 sites over the area of the cranial sutures. Adverse events and potential beneficial effects were recorded in a headache diary at least 4 weeks before, and for 12 weeks after the injections. A higher dilution than normal of onabotulinimtoxin A was used to get better diffusion. Results Nineteen (of 20 included) women with chronic migraine received the injections and were evaluable. There was only one treatment-related adverse event (reduced power of chewing for some weeks). Otherwise, the procedure was overall well tolerated. Patients improved on most efficacy parameters after the injections. There was little or no effect on glabellar or forehead lines. Conclusions The protocol was safe and well tolerated. Lower risk of unblinding due to the absence of cosmetic effects should make the injection procedure well suited for a large, randomized, placebo-controlled study. If efficacy is confirmed, it will be markedly less costly than the standard procedure. Trial registration: EUDRACT (2017-002516-13), (NCT03543254).en_US
dc.publisherSage Publishingen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleFollowTheSutures: Piloting a new way to administer onabotulinumtoxinA for chronic migraine.en_US
dc.title.alternativeFollowTheSutures: Piloting a new way to administer onabotulinumtoxinA for chronic migraine.en_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.relation.projectNorges forskningsråd: 328615en_US

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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal