Pediatric MigraineNCT07103031
Comorbidity-Based Propranolol Use in Pediatric Migraine
An observational study of Pediatric Migraine and Migraine Disorders, Brain, run by Kayseri University at 1 site in Turkey (Türkiye).
Trial summary
This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Pediatric Migraine, Migraine Disorders, Brain, Vitamin D Deficiency
- What is being tested?
- Behavioral therapy and Propranolol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 488 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consisted of pediatric patients aged [2-19] who were diagnosed with primary headache disorders, specifically migraine, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants were evaluated and followed at the pediatric neurology outpatient clinic of a tertiary care hospital between January 2021 and December 2023. Patients with confirmed comorbid conditions (e.g., anxiety, benign paroxysmal vertigo, essential tremor) and/or vitamin deficiencies were included to assess the impact of these factors on treatment response. Those with secondary headache, neurological disorders, or incomplete records were excluded.
Who may be able to join
- Children aged 0-20 years
- Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Clinical and/or neurological evaluation consistent with primary headache
- Completed baseline PedMIDAS and VAS assessments
- Available for 3-month follow-up after initiation of treatment
Who cannot join
- Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings
- Failure to meet ICHD-3 diagnostic criteria for primary headache
- Presence of structural brain lesions or other neurological disorders
- Chronic systemic illness or current use of other migraine prophylactic medications
- Incomplete data or loss to follow-up within the 3-month period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting The Right Pediatric Migraine Patient: A Comorbidity-Oriented Approach To Propranolol Prophylaxis
This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.
Read the detailed description
Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use.
This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.
- Being tested
- Behavioral therapy, Propranolol
- Keywords
- Propranolol, Pediatric Migraine, Migraine Prophylaxis, Vitamin D Deficiency
- Medical subject headings
- Migraine Disorders, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapyBehavioural
Also called Cognitive-Behavioral Therapy
Patients in PedMIDAS stage 1-2 (score ≤ 30) received behavioral therapy including lifestyle counseling, stress management techniques, sleep hygiene education, and individualized headache triggers review. Additionally, each patient was provided with a headache report card to self-monitor symptoms, triggers, and medication use over a 3-month period.
PropranololDrug
Also called β-blocker
Patients in PedMIDAS stage 3-4 (score > 30) received oral propranolol treatment at a dose of 1-3 mg/kg/day, adjusted by weight and tolerance, for a total of 3 months. The medication was prescribed and monitored by a pediatric neurologist. Patients were followed with routine check-ups and adverse effects were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Behavioral therapy group Receives: Behavioral: Behavioral therapy | |
| Group 2 | Propranolol group Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score
The primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response.
Measured: Baseline to 3 months after treatment
Secondary outcomes (1)
Visual Analog Scale (VAS) Pain Scores
VAS pain scores range from 0 (no pain) to 10 (worst imaginable pain). The change in VAS score after 3 months of treatment reflects the patient's subjective pain improvement.
Measured: Baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric MigraineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge BAYKAN ÇOPUROĞLU, Kayseri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103031
- Sponsor's protocol ID
- KayseriUniversity12
- Other IDs
- EC/IRB Number- 2021/12-14
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting The Right Pediatric Migraine Patient: A Comorbidity-Oriented Approach To Propranolol Prophylaxis
- ClinicalTrials.gov ID
- NCT07103031
- Acronym / sponsor ID
- KayseriUniversity12
- Keywords
- Propranolol, Pediatric Migraine, Migraine Prophylaxis, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Kayseri UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Aug 2025 (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 observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.
Detailed description
Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use.
This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Behavioral therapyBehavioral therapy group |
| Group 2 | – | Drug: PropranololPropranolol group |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of pediatric patients aged [2-19] who were diagnosed with primary headache disorders, specifically migraine, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants were evaluated and followed at the pediatric neurology outpatient clinic of a tertiary care hospital between January 2021 and December 2023. Patients with confirmed comorbid conditions (e.g., anxiety, benign paroxysmal vertigo, essential tremor) and/or vitamin deficiencies were included to assess the impact of these factors on treatment response. Those with secondary headache, neurological disorders, or incomplete records were excluded.
Key inclusion criteria (5 listed)
- Children aged 0-20 years
- Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Clinical and/or neurological evaluation consistent with primary headache
- Completed baseline PedMIDAS and VAS assessments
- Available for 3-month follow-up after initiation of treatment
Key exclusion criteria (5 listed)
- Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings
- Failure to meet ICHD-3 diagnostic criteria for primary headache
- Presence of structural brain lesions or other neurological disorders
- Chronic systemic illness or current use of other migraine prophylactic medications
- Incomplete data or loss to follow-up within the 3-month period
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 |
|---|---|---|
| Behavioral therapyAlso: Cognitive-Behavioral TherapyPatients in PedMIDAS stage 1-2 (score ≤ 30) received behavioral therapy including lifestyle counseling, stress management techniques, sleep hygiene education, and individualized headache triggers review. Additionally, each patient was provided with a headache report card to self-monitor symptoms, triggers, and medication use over a 3-month period. | Behavioural | Group 1 |
| PropranololAlso: β-blockerPatients in PedMIDAS stage 3-4 (score > 30) received oral propranolol treatment at a dose of 1-3 mg/kg/day, adjusted by weight and tolerance, for a total of 3 months. The medication was prescribed and monitored by a pediatric neurologist. Patients were followed with routine check-ups and adverse effects were recorded. | Drug | Group 2 |
Primary outcome
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score
Time frame: Baseline to 3 months after treatment
The primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response.
1 secondary outcome
Visual Analog Scale (VAS) Pain Scores
Time frame: Baseline to 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Migraine and Migraine Disorders, Brain, run by Kayseri University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score (time frame: Baseline to 3 months after treatment). 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 5 Aug 2025.