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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nishtar Hospital Multan Coordinator of this site? Confirm its status | Multan | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.