Could a Brussels-backed study change how Belgium prevents migraine?

A neurologist at UZ Brussel has helped produce the strongest direct evidence yet that a migraine-specific tablet may outperform one of Belgium’s established preventive treatments. The international TEMPLE trial, published online in The Lancet Neurology on 23 July and highlighted by the Brussels hospital on 20 August, found that adults assigned atogepant had fewer migraine days and were less likely to stop treatment because of side effects than those assigned topiramate.

That finding has immediate relevance in Belgium because both medicines sit at different points in the treatment pathway. Topiramate, originally developed for epilepsy, has long been used to prevent migraine. Atogepant, sold in the European Union as Aquipta, targets receptors associated with calcitonin gene-related peptide, or CGRP, and was developed specifically for migraine. Belgian reimbursement rules nevertheless generally require eligible patients to have tried topiramate and several other preventive options before atogepant can be reimbursed, according to the rules reproduced by the Belgian Centre for Pharmacotherapeutic Information from RIZIV.

TEMPLE enrolled 545 adults with episodic or chronic migraine across 12 countries, including Belgium. Participants had at least four migraine days a month on average and received one of the two daily treatments for 24 weeks in a randomised, double-blind comparison. UZ Brussel says 64.1% of those assigned atogepant achieved at least a 50% reduction in monthly migraine days during the final three months, compared with 39.3% on topiramate.

The average monthly reduction was 6.3 migraine days with atogepant and 4.5 with topiramate, a difference of 1.8 days. The trial’s primary outcome concerned tolerability: 12.1% of participants taking atogepant stopped because of adverse effects, against 29.6% taking topiramate. Treatment-related adverse events were reported by 56% and 78% respectively, UZ Brussel reported.

Professor Jan Versijpt, the UZ Brussel neurologist and VUB academic who co-authored the study, framed adherence as central to the result: preventive medicine can work only when patients tolerate it well enough to continue. The author list also includes Annelies Van Dycke of AZ Sint-Jan Bruges, giving the Belgian contribution a wider footprint than the Brussels hospital alone.

There are, however, reasons for restraint. AbbVie, which markets atogepant, funded the phase 3b trial, and several authors are affiliated with the company. The published abstract reports one drug-related serious adverse event, an anaphylactic reaction, in the atogepant group. The blinded comparison lasted 24 weeks, so it cannot settle questions about effectiveness, uncommon harms or persistence over several years. UZ Brussel itself stresses that topiramate remains effective for some patients and that atogepant is not automatically the best or most accessible option for everyone.

The regulatory and reimbursement perspectives are also distinct. The European Medicines Agency has authorised Aquipta for migraine prevention in adults with at least four migraine days per month, judging its benefits greater than its risks. Belgium’s RIZIV-backed reimbursement framework is narrower: it requires at least eight documented migraine days per month, prior failure or intolerance of several preventive treatments, specialist authorisation and evidence of a sufficient response for continued coverage. The current listed co-payment is €12.80 under ordinary reimbursement or €8.50 for people receiving increased reimbursement, according to the BCFI database.

That gap reveals the broader issue raised by the study. A medicine may be clinically superior in a head-to-head trial without immediately becoming the default first choice in a publicly financed health system. Regulators decide whether it may be sold; clinicians decide whether it suits an individual patient; reimbursement authorities must also weigh comparative value and budget impact.

For patients in Brussels and elsewhere in Belgium, the practical message is therefore not to switch treatment independently, but to discuss persistent attacks or troublesome side effects with a neurologist. The next evidence will come from longer follow-up and more diverse patient groups. The policy question is whether TEMPLE’s direct comparison is strong enough to prompt Belgian authorities to reconsider where atogepant belongs in the reimbursed treatment sequence; no such revision has yet been announced in the sources reviewed.