OnabotulinumtoxinA blockade of the sphenopalatine ganglion in treatment-resistant chronic migraine (MiBlock): rationale, design and study protocol for a multi-centre, investigator initiated, randomised, quadruple-blinded placebo-controlled trial
Abstract
Background: Treatment-resistant chronic migraine patients constitute a heavily burdened patient population with need for novel treatment options. The sphenopalatine ganglion (SPG), located deep within the facial structures, is a synaptic junction in the trigemino-autonomic reflex that is hypothesised to play a part in migraine pathophysiology. A 2017 open-label pilot study explored the SPG as a target for onabotulinumtoxinA injections in chronic migraine using a navigation-guided injection device, demonstrating a favourable safety profile and promising response on migraine related efficacy outcomes.
Methods: MiBlock is a multi-centre, investigator-initiated, publicly funded, randomised, quadruple-blinded and placebo-controlled trial. Participation is voluntary and all participants must sign a written consent prior to inclusion. The study is approved by the Norwegian ethics committee and the Norwegian Medical Product Agency. Patients with treatment-resistant chronic migraine will be recruited from four Norwegian university hospitals until 170 have received study treatment. The study will investigate the efficacy of a single-session, bilateral, navigation-guided, percutaneous injection of either onabotulinumtoxinA (verum) or 0.9% NaCl (placebo) towards the SPG under local anaesthesia. The primary efficacy endpoint is the change from baseline in the frequency of moderate and severe headache days at weeks 5-8 post-injection. The primary efficacy outcome variable is collected…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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