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NCT07743255Enrolling by invitation

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
60 (estimated)
First submitted
29 Jul 2026
Start date
10 Jun 2026
Primary completion date
10 Dec 2026
Lead sponsor
Nishtar Medical University
Diseases
Migraine
NCT number
NCT07743255

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 10 Jun 2026 to the primary completion date, 10 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of prophylactic migraine medications (other than those being evaluated in the study) or recent discontinuation within the last four weeks.

Other illness

  • Presence of chronic medical conditions affecting the central nervous system, such as epilepsy, neurodegenerative diseases, or brain tumors.
  • Patients with diagnosed primary sleep disorders not related to migraine.
  • Known allergy or hypersensitivity to melatonin, propranolol, or any related medication used in the study.

Who the study is looking for

  • Patients aged 5 to 15 years.
  • Both male or female.
  • Confirmed diagnosis of migraine (with or without aura) based on the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
  • Patients with a PEDMIDAS score ≥11, indicating moderate to severe migraine-related disability.

Age in the registry: 5 years to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Nishtar Hospital Multan
Coordinator of this site? Confirm its status
MultanPakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.