Comparison of Propranolol, Flunarizine and Their Combination in Preventing Migraine in Adults in a Tertiary Care Hospital in Bangladesh
Starting soon · Phase 4
Conditions studied: Migraine Prophylaxis
In brief
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.
Key facts
- Study ID
- NCT07655700
- Run by
- Chittagong Medical College
- People needed
- 177
- Starts
- 2026-07-01
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Comorbidities:
- 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).
- Medications:
- Received migraine prophylactic medication within 60 days prior to screening.
- Use of specific contraindicated medications, including beta-blockers or calcium channel blockers, except as part of the study treatments.
- Non-compliance:
- Inability or unwillingness to comply with study protocols, including maintaining a headache diary or attending follow-up visits.
- History of Allergies:
- Known hypersensitivity to propranolol, flunarizine
- Substance Use:
- Current substance abuse
Where it is running
- Chittagong Medical College — Chittagong, Bangladesh
Full record on ClinicalTrials.gov
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