A comparative study of the efficacy of coenzyme Q10 and amitriptyline in the prophylactic treatment of migraine headaches in children; An open-label randomized controlled trial

Evaluation and comparison of the efficacy of Q10 and amitriptyline in the prevention of childhood migraine headaches

A randomized, open-labeled clinical trial with 2 parallel groups, design of 72 patients, enrolled from August 2019, and followed for 4 months

This study include children referred to pediatric neurology clinic in Imam Hosein children hospital, Isfahan. Only, data analyzers remains blind in this survey.

Inclusion criteria: 1) Children 5 to 15 year old with migraine with or without aura referred to a clinic of neurology and disease is diagnosed definitively on the basis of IHS 2) Migraine attacks occur at least twice a week or four times a month, forcing them to consume or disrupt their daily activities Exclusion criteria: 1) Patients' unwillingness to cooperate during the study 2) Severe and uncontrolled side effects of Q10 or Amitriptyline 3) If a diagnosis other than migraine is made during the study, based on possible laboratory or imaging findings. 4) Complicated migraine or epilepsy 5) Lack of ability to record data on the frequency, duration, and severity of headaches 6) Taking prophylaxis other than Q10 and amitriptyline 7) Children with migraines with severe psychiatric problems such as ADHD and depression 8) Using painkillers more than 4 times a week to control migraine attacks (severe forms of migraines) 9) A history of allergy to similar drugs used

In this study, participants are divided into groups A and B, group A is treated with Q10 and group B is treated with Amitriptyline. Patients are fallowed up for three months for the frequency, duration, and severity of migraine attacks and drug side effects.

Headaches frequency; Headaches duration, Headaches severity, Patients quality of life

In this clinical trial, which begins in summer 2019, 72 participants are selected from the patients referred to the neurology department of Imam Hossein Hospital in a non-randomized and simple method, if they met the inclusion criteria. Adequate explanations will be given to parents and informed consents will be obtained. Patients were randomly assigned using SPSS generated random numbers and binary blocks to either A or B groups (Coenzyme Q10 or Amitriptyline) at the time of administering treatment. In this study, participants will be divided into two groups after allocation of code to each patient and then randomly dividing the codes between two groups and the person in charge is blind to participants.

In this study, physicians and patients will aware of study groups and only, statistical analyser will be blind for treatment groups. Each group will be assigned with A or B, making the analyser blind for the treatment groups.