Study Protocol for Assessing the Effectiveness of Agomelatine on the Severity and Frequency of Episodic Migraine Attacks Without Aura: A Randomized Triple-Blind, Placebo-Controlled Trial

Abstract

Background: Migraine is a chronic condition characterized by moderate to severe headache attacks, adversely affecting individual and social quality of life. Given the chronic nature of this disease, it is crucial to find medications that offer fewer side effects and enhanced effectiveness. Agomelatine, a synthetic analogue of the hormone melatonin, shares similar pharmacodynamics, such as stimulating melatonin receptors and inhibiting the 5HT2c receptor. Due to its favorable side-effect profile and high tolerability, agomelatine presents a viable alternative to traditional preventive treatments for migraines. Objectives: The primary objective of this trial is to evaluate the effectiveness of agomelatine in reducing the severity and frequency of episodic migraine attacks without aura. Methods: This study utilizes a parallel, triple-blind controlled trial design. Patients, aged between 18 and 60 years, who have been definitively diagnosed with episodic migraine without aura and have not received prior severity treatment, are eligible for this randomized controlled trial (RCT). A convenience sample of patients will be recruited from individuals visiting the clinic for migraine issues. If these individuals agree to participate and meet the inclusion criteria, they will be randomly assigned to either the intervention or control group using a random number table or software. The intervention group will receive 25 mg of agomelatine daily, while the control group will be given vitamin B1 as a placebo. Both the frequency and severity of migraine attacks will be monitored, along with the mean monthly migraine days (MMD) and migraine disability assessment (MIDAS) scores, before and after the intervention.