Study of Combined CGRP Monoclonal Antibody and Onabotulinumtoxin A Therapy Compared to CGRP Monoclonal Antibody Alone for Preventing Chronic Migraine in Adults Aged 18 to 70

What this Trial Is About

Researchers are evaluating treatments for chronic migraine, a condition marked by 15 or more headache days per month for over three months, with at least eight days featuring migraine symptoms. This trial aims to assess the effectiveness of combining onabotulinumtoxin A with CGRP monoclonal antibody therapy compared to CGRP therapy alone in preventing chronic migraine attacks. The study also monitors side effects and changes in disease activity, involving about 450 participants in Norway aged 18 to 70 years. Participants will all receive monthly CGRP monoclonal antibody injections as background treatment. They will be randomly assigned to receive either onabotulinumtoxin A injections 155 units at 31 muscle sites or placebo injections following a modified PREEMPT protocol. The treatment period lasts 12 weeks. Before starting treatment, participants will record headache data using an electronic diary app for at least four weeks. The study includes three in-person visits and three telephone visits across a total of 20 weeks. During the study, participants keep detailed headache diaries to track frequency, intensity, medication use, and headache type. Telephone follow-ups at weeks 4 and 8 review treatment adherence and safety. After 12 weeks of treatment, a clinical visit assesses study outcomes, including changes in monthly migraine days and headache severity. Participants continue diary entries for an additional four weeks until the final telephone visit, marking the studys end. The primary outcome is the reduction in monthly migraine days over 12 weeks.

The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy