This is a randomized, triple-blind, placebo-controlled, parallel group study in adult subjects with diagnosis of migraine with or without aura. All patients will be assessed in a screening visit at the Study Hospital Dept. of Neurology in order to confirm and certify migraine diagnosis and evaluate correctness and stability of usual acute and preventive standardized pharmacological treatment. Patients will fulfill a 30 day baseline period to monitor headache activity, migraine related symptoms, and medication usage. Subjects agreeing to participate in the study and meeting clinical-neurological eligibility criteria will then assist to a first homeopathic consultation to assess viability of homeopathic treatment and selection of the individualized homeopathic remedy. Patients who meet both neurological and homeopathic inclusion criteria will begin a three month treatment phase. An estimated of 72 patients, calculated according to the Open-Epi program ((c) 2003, 2008 Andrew G. Dean and Kevin M. Sullivan, Atlanta, GA, USA) , will be randomized according to statistics Epidat Program (4.2 version, july 2016 Panamerican Health Organization (PHO-WHO); to receive Individualized homeopathic treatment + standard pharmacological treatment OR unidentified placebo + standard pharmacological treatment. Study homeopathic remedy or placebo will be administered for a minimum period of 12 weeks with control visits every 4 weeks to assess neurological and homeopathic evolution, adherence and possible adverse events. During the study period patients will continue filling the migraine diary collecting frequency, length and type of headaches, acute medication usage and migraine associated symptoms. At the end of treatment, a final clinical homeopathic visit will take place as well as a final Neurological visit at study Hospital. Hospital visits are independent of clinical visits and performed by different study physicians.~After conclusion of treatment phase patients will have three more follow up visits for the assessment of clinical and homeopathic evolution, possible adverse events and general satisfaction with the study.
Migraine, a chronic and often lifelong neurological disorder, is the second leading cause of years lived with disability worldwide. To reduce this global burden, concerted efforts are needed to implement and improve migraine health-care policies. Several observational studies showed significant improvement of different headaches types with homeopathy. The purpose of this study is the assessment of the efficacy of Individualized Homeopathic Remedies (specific remedies for each patient) versus Conventional pharmacological treatment in patients with migraine.