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Melatonin may double up against childhood migraines

NCT ID NCT07743255

Disease control Sponsor: Nishtar Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether adding melatonin to the standard preventive drug propranolol can better reduce migraine attacks in children aged 5 to 15. Sixty children with moderate-to-severe migraine disability will receive either melatonin plus propranolol or propranolol alone for three months. Researchers will track attack frequency, pain severity, disability, and side effects to see if the combination offers extra relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin 3 mg at bedtime plus propranolol 1 mg/kg/day, compared with propranolol alone
What this could lead to
If adding melatonin works, it could offer a simple, well-tolerated way to reduce migraine attacks and disability in children, improving daily life.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. Melatonin may not add benefit over propranolol alone, and propranolol can cause low blood pressure or slow heart rate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 15 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

migraine disorder migraine with aura migraine without aura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nishtar Hospital Multan

    Multan, Punjab Province, 66000, Pakistan

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