Migraine DisordersNCT07743255
Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine
A study testing Melatonin and Propranolol in people with Migraine Disorders, run by Nishtar Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Melatonin and Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2026to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial
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
- Being tested
- Melatonin, Propranolol
- Keywords
- Pediatric Migraine, Migraine with Aura, Migraine without Aura, Melatonin, Propranolol
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol.
PropranololDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Months 1, 2, and 3
Secondary outcomes (1)
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.
Measured: Baseline and Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start10 Jun 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazia Parveen, Nishtar Medical University
- Investigators
- Shazia Parveen, Principal investigator, Nishtar Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743255
- Sponsor's protocol ID
- NMU1
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07743255
- Acronym / sponsor ID
- NMU1
- Conditions
- Migraine Disorders
- Keywords
- Pediatric Migraine, Migraine with Aura, Migraine without Aura, Melatonin, Propranolol
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin Plus Propranolol | Experimental | Drug: Melatonin, Drug: PropranololParticipants 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. |
| Propranolol Alone | Active comparator | Drug: PropranololParticipants received propranolol 1 mg/kg/day orally in two equal divided doses for three months without melatonin. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninMelatonin 3 mg was administered orally once daily at bedtime for three months in addition to propranolol. | Drug | Melatonin Plus Propranolol |
| PropranololPropranolol 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. | Drug | Melatonin Plus Propranolol, Propranolol Alone |
Primary outcome
Change in Monthly Migraine Attack Frequency
Time frame: Baseline and Months 1, 2, and 3
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.
Change in Migraine Pain Severity
Time frame: Baseline and Months 1, 2, and 3
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.
1 secondary outcome
Change in Migraine-Related Disability
Time frame: Baseline and Month 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shazia Parveen principal investigator
Nishtar Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Propranolol in people with Migraine Disorders, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monthly Migraine Attack Frequency (time frame: Baseline and Months 1, 2, and 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.