An interventional study of Melatonin and Propranolol in Migraine Disorders, sponsored by Nishtar Medical University. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Nishtar Medical University · Not applicable, Interventional, and Treatment
This randomized controlled trial evaluated whether adding melatonin to propranolol provided better prevention of migraine in children than propranolol alone. The study included 60 children aged 5-15 years with migraine, diagnosed according to the International Classification of Headache Disorders criteria, who attended the Pediatric Outpatient Department of Nishtar Hospital, Multan. Participants were randomly assigned in equal numbers to receive either melatonin 3 mg at bedtime plus propranolol 1 mg/kg/day in two divided doses, or propranolol 1 mg/kg/day alone, for three months.
Migraine attacks, pain severity, attack duration, migraine-related disability, use of pain-relieving medicines, treatment adherence, and adverse effects were recorded at baseline and during follow-up visits at one, two, and three months. Parents or caregivers maintained a daily headache and medication diary throughout the treatment period. Blood pressure and pulse rate were also monitored because propranolol may cause low blood pressure or a slow heart rate.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received melatonin 3 mg orally once daily at bedtime together with propranolol 1 mg/kg/day orally in two equal divided doses for three months.
Drug: Melatonin · Drug: Propranolol
Participants received propranolol 1 mg/kg/day orally in two equal divided doses for three months without melatonin.
Drug: Propranolol
Melatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol.
Propranolol 1 mg/kg/day was administered orally in two equal divided doses, equivalent to 0.5 mg/kg per dose in the morning and evening, for three months.
Change in Monthly Migraine Attack Frequency
Monthly migraine attack frequency was defined as the number of migraine attacks occurring during a 30-day period, as recorded by the parent or caregiver in the daily headache diary. Separate attacks were identified by a pain-free interval of at least 24 hours. Change from baseline was calculated by comparing the number of attacks recorded before treatment with the number recorded during follow-up. A greater reduction indicated better preventive efficacy.
Time frame: Baseline and Months 1, 2, and 3
Change in Migraine Pain Severity
Migraine pain severity was assessed using a 0-10 Visual Analog Scale, where 0 represented no pain and 10 represented the worst possible pain. The parent, caregiver, or child recorded the severity of each migraine attack in the headache diary. The average pain score for each 30-day assessment period was calculated and compared with the baseline value. A greater reduction indicated improvement in migraine severity.
Time frame: Baseline and Months 1, 2, and 3
Change in Migraine-Related Disability
Migraine-related disability was assessed using the Pediatric Migraine Disability Assessment questionnaire. The total score was calculated from six questions evaluating missed or impaired school, home, social, and recreational activities during the preceding three months. Scores were categorized as minimal disability, 0-10; mild disability, 11-30; moderate disability, 31-50; and severe disability, greater than 50. A lower score indicated less migraine-related disability.
Time frame: Baseline and Month 3.
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Studies of the drug tested here: Melatonin
Nishtar Medical University