Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

NCT07743255 | Enrolling By Invitation

• 1 other identifier: NMU1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Disorders

Keywords

Pediatric Migraine; Migraine with Aura; Migraine without Aura; Melatonin; Propranolol

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and Months 1, 2, and 3

Secondary Outcomes (1)

• Change in Migraine-Related Disability

  Baseline and Month 3.

Study Arms (2)

Melatonin Plus Propranolol

EXPERIMENTAL

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

Propranolol Alone

ACTIVE COMPARATOR

Participants received propranolol 1 mg/kg/day orally in two equal divided doses for three months without melatonin.

Drug: Propranolol

Interventions

Melatonin DRUG

Melatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol.

Melatonin Plus Propranolol

Propranolol DRUG

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.

Melatonin Plus Propranolol; Propranolol Alone

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Presence of chronic medical conditions affecting the central nervous system, such as epilepsy, neurodegenerative diseases, or brain tumors.
• Current use of prophylactic migraine medications (other than those being evaluated in the study) or recent discontinuation within the last four weeks.
• 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.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Hospital Multan

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Interventions

Melatonin; Propranolol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Shazia Parveen

  Nishtar Hospital Multan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

PA (1)