133 Rationale and protocol of the WHAT! Trial 6 Data category Information 19. Primary outcome(s) • Number of migraine days [Time Frame: From baseline to the last 4 weeks of treatment (weeks 9-12)] o Change in monthly migraine days 20. Key secondary outcomes • Number of headache days [Time Frame: From baseline to the last 4 weeks of treatment (weeks 9-12)] o Change in monthly headache days • Number of migraine attacks [Time Frame: From baseline to the last 4 weeks of treatment (weeks 9-12)] o Change in monthly migraine attacks • Number of probable migraine attacks [Time Frame: From baseline to the last 4 weeks of treatment (weeks 9-12)] o Change in monthly probable migraine attacks • Number of 50% responders [Time Frame: From baseline to the last 4 weeks of treatment (weeks 9-12)] o Patients who had ≥50% reduction in the number of migraine days • (Serious) adverse events [Time Frame: Up to 3 months] o Occurrence of adverse events and serious adverse events 21. Ethics Review Ethical approval was assigned by the CCMO of the Netherlands (NL67994.058.19). All participating patients will provide written informed consent. 22. Completion date 2024-12 (Final data collection date for primary outcome measure) 23. Summary Results Not completed yet 24. IPD sharing statement Plan to Share IPD: no Ethical considerations The study is performed in accordance with the declaration of Helsinki Ethical Principles and Good Clinical Practices. The study design has been approved by the local and national ethics committees of the Netherlands (NL67994.058.19). In case of a protocol modification, the investigators, ethics committees and clinical trial registries will be informed trough written communication. Informed consent is obtained from all participants before inclusion. No financial rewards will be granted to participants. Travel expenses will be compensated. A data monitoring committee (DMC) is established to oversee the safety and integrity of the study. This committee is an independent committee, consisting of an epidemiologist and a statistician. Both members have no conflict of interest with the principal investigator of the study. They are tasked with interim analyses on safety data and can advise on early termination of the trial. The advice of the DSMB will only be sent to the principal investigator of the study. Should the principal investigator decide not to fully implement the advice of the DSMB, the principal investigator will send the advice to the reviewing ethical committee of the Netherlands, including a note to substantiate why (part of) the advice of the DSMB will not be followed. Auditing is conducted twice a year at the LUMC by an internal pool of monitors. The auditing process is independent of both the investigators and the sponsor.
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