Migraine is a common and disabling neurological condition that affects quality of life, work productivity, and daily functioning. In Bangladesh, migraine is a major health problem, yet access to effective and affordable preventive treatments remains limited. Preventive (prophylactic) treatment is recommended for people who experience frequent migraine attacks in order to reduce the number, severity, and duration of headaches.
Propranolol and flunarizine are two commonly used and relatively inexpensive medications for migraine prevention. Both drugs have been shown to reduce migraine frequency when used alone. However, some patients do not respond adequately to a single medication. Using a combination of drugs that work through different mechanisms may improve treatment effectiveness without significantly increasing side effects. There is limited local evidence comparing propranolol, flunarizine, and their combination in migraine prevention, particularly in the Bangladeshi population.
This study is designed to compare the effectiveness and safety of propranolol alone, flunarizine alone, and a combination of propranolol and flunarizine in preventing episodic migraine in adults. The main hypothesis is that at least one of these treatment strategies, particularly combination therapy, may be more effective than the others in reducing migraine burden.
This is an open-label, parallel-arm, randomized controlled trial conducted at Chittagong Medical College Hospital, Bangladesh. A total of 177 adult patients aged 18 to 55 years who are diagnosed with episodic migraine and experience four or more migraine attacks per month will be enrolled. Participants will be randomly assigned to one of three treatment groups: propranolol, flunarizine, or a combination of both medications. Treatment will be given for 12 weeks, with dose adjustments during the first week and follow-up visits at 6 and 12 weeks.
The primary outcome of the study is the reduction in the number of monthly migraine days. Secondary outcomes include the proportion of patients achieving at least a 50% reduction in migraine days, changes in headache severity and duration, improvement in migraine-related disability (measured by the Migraine Disability Assessment Score), patient-reported treatment satisfaction, and the frequency of side effects.
The results of this study are expected to provide important local evidence to guide clinicians in selecting effective and affordable migraine preventive treatments and to clarify whether combination therapy offers additional benefits over single-drug therapy in routine clinical practice.
Participants aged 18 to 55 years.
Diagnosis of episodic migraine, defined according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
Participants experiencing 4 or more migraine attacks per month.
Willingness to provide written informed consent to participate in the study.
Presence of other primary headache disorders, chronic migraine, hemiplegic migraine, basilar migraine or any secondary headache disorder.
Known serious underlying systemic diseases including Cardiac disease (Heart failure, Heart Block, Arrhythmia), Renal dysfunction, Liver dysfunction, Pulmonary disease (Asthma, COPD), Peripheral vascular disease, Extrapyramidal disease (Parkinson disease, Chorea, Dystonia).
Pregnancy or breastfeeding.
Psychiatric illness (Depression, Psychosis, Obsessive compulsive disorder).
Parallel
Propranolol 80 mg
DrugParticipants randomized to propranolol arm will receive propranolol as the sole prophylactic medication for migraine, administered for a total of 12 weeks. Propranolol will be started at 40 mg daily and increased to 80 mg daily after 7 days
Flunarizine 10 mg
DrugParticipants randomized to flunarizine arm will receive flunarizine as the sole prophylactic medication for migraine, administered for a total of 12 weeks. Flunarizine will be started at 5 mg daily and increased to 10 mg daily after 7 days
Propranolol 40 mg + Flunarizine 10mg
DrugParticipants randomized to combination arm will receive a combination of propranolol and flunarizine for migraine prophylaxis, administered for a total of 12 weeks. Treatment will be started at propranolol 40 mg daily plus flunarizine 5 mg daily. After 7 days, the propranolol dose will be maintained at 40 mg daily while the flunarizine dose will be increased to 10 mg daily.
Change in Monthly Migraine Days
Monthly Migraine Days refers to the total number of days within a month on which a participant experiences a migraine headache. The change will be measured as the difference between the baseline number of monthly migraine days and the number recorded at the end of the study.
Responder Rate (≥50% reduction in monthly migraine days)
The percentage of patients reporting at least a 50% reduction in their monthly migraine days compared to the baseline. This will be expressed as the percentage of total participants in each treatment arm.
Change in Headache Severity (Numeric Rating Scale)
Intensity of migraine pain rated by participants on a Numeric Rating Scale from 0 (no pain) to 10 (worst pain imaginable), recorded in the headache diary and reviewed at follow-up visits.
Change in Headache Duration
Length of time (in hours) of each migraine attack, from onset of pain to resolution, as recorded by participants in the headache diary and reviewed at follow-up visits.
Change in MIDAS (Migraine Disability Assessment) Score
Score from the Bengali-translated MIDAS questionnaire (adapted from Alam et al., 2018, used with author's permission), measuring migraine-related disability across work/school, household duties, and other daily activities, graded from Grade 1 (minimal disability) to Grade 4 (severe disability).
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