Pascual, Julio

Background Validated chronic migraine biomarkers could improve diagnostic, prognostic, and predictive abilities for clinicians and researchers, as well as increase knowledge on migraine pathophysiology. Objective The objective of this narrative review is to summarise and interpret the published literature regarding the current state of development of chronic migraine biomarkers. Findings Data from functional and structural imaging, neurophysiological, and biochemical studies have been utilised towards the development of chronic migraine biomarkers. These biomarkers could contribute to chronic migraine classification/diagnosis, prognosticating patient outcomes, predicting response to treatment, and measuring treatment responses early after initiation. Results show promise for using measures of brain structure and function, evoked potentials, and sensory neuropeptide concentrations for the development of chronic migraine biomarkers, yet further optimisation and validation are still required. Conclusions Imaging, neurophysiological, and biochemical changes that occur with the progression from episodic to chronic migraine could be utilised for developing chronic migraine biomarkers that might assist with diagnosis, prognosticating individual patient outcomes, and predicting responses to migraine therapies. Ultimately, validated biomarkers could move us closer to being able to practice precision medicine in the field and thus improve patient care.

In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy, and these Guidelines would ‘improve the quality of controlled clinical trials in migraine’. With the current trend for large multinational trials, there is a need for increased awareness of methodological issues in clinical trials of drugs and other treatments for chronic migraine. These Guidelines are intended to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents.