Pediatric MigraineNCT07180043
Propranolol for Pediatric Migraine: A Prospective Clinical Study
A study testing Structured Behavioral Therapy and Propranolol in people with Pediatric Migraine and Headache Disorders, run by Kayseri University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, controlled clinical trial was conducted to evaluate the effectiveness of propranolol compared with structured behavioral therapy in pediatric patients diagnosed with primary migraine according to ICHD-3 criteria. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pediatric Migraine, Headache Disorders
- What is being tested?
- Structured Behavioral Therapy and Propranolol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Dec 2023
- Phase
- Interventional
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of primary migraine (with or without aura) according to ICHD-3 criteria
- Age between 6 and 16 years
- Minimum of 4 migraine attacks per month
- No history of prophylactic migraine therapy within the last 3 months
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Secondary headaches due to underlying pathologies (e.g., tumors, infections, vascular malformations)
- Chronic systemic or psychiatric disorders (e.g., epilepsy, major depression)
- Contraindications to propranolol (e.g., asthma, cardiac conduction defects)
- Incomplete clinical data or loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Predictors of Propranolol Responsiveness in Pediatric Migraine: A Prospective Observational Study
This prospective, controlled clinical trial was conducted to evaluate the effectiveness of propranolol compared with structured behavioral therapy in pediatric patients diagnosed with primary migraine according to ICHD-3 criteria. A total of 178 children aged 6 to 16 years were enrolled between January 2021 and December 2023 at a tertiary pediatric neurology center.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores: Group 1 received standardized behavioral therapy, while Group 2 received propranolol at doses ranging from 1-3 mg/kg/day for 12 weeks. Primary outcomes included changes in PedMIDAS and Visual Analog Scale (VAS) scores. Secondary analyses investigated clinical and biochemical predictors of propranolol responsiveness, including benign paroxysmal vertigo, essential tremor, anxiety, vitamin D status, and vitamin B12 levels.
The study aims to provide evidence for a more personalized approach to migraine prophylaxis in children by integrating clinical, psychiatric, and nutritional predictors of treatment response.
Read the detailed description
Migraine is among the most common neurological disorders in children and adolescents, often leading to significant disability, reduced school performance, and impaired quality of life. Although propranolol is frequently prescribed for pediatric migraine prophylaxis, previous studies have reported heterogeneous outcomes, and clinical predictors of treatment response remain unclear.
This prospective, controlled clinical trial was designed to assess the comparative effectiveness of propranolol and structured behavioral therapy in pediatric migraine patients and to identify predictors of response to propranolol. A total of 178 children, aged 6-16 years, diagnosed with primary migraine according to ICHD-3 criteria, were consecutively recruited at a tertiary pediatric neurology center between January 2021 and December 2023.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores:
Group 1 (n = 88) received structured behavioral therapy, including patient education, lifestyle guidance, and headache diary maintenance.
Group 2 (n = 90) received oral propranolol at doses of 1-3 mg/kg/day for 12 weeks, with adherence monitored through logs and follow-up calls.
The primary outcomes were changes in PedMIDAS and Visual Analog Scale (VAS) scores after 12 weeks. Secondary outcomes included identification of clinical, psychiatric, and biochemical predictors of treatment responsiveness. Particular attention was given to benign paroxysmal vertigo, essential tremor, anxiety traits, and micronutrient deficiencies (vitamin D and vitamin B12).
- Conditions
- Pediatric Migraine, Headache Disorders
- Being tested
- Structured Behavioral Therapy, Propranolol
- Keywords
- Pediatric Migraine, Propranolol, Behavioral Therapy
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Behavioral TherapyBehavioural
Structured patient education, lifestyle modification counseling, and headache diary maintenance without pharmacological prophylaxis.
PropranololDrug
Oral propranolol, 1-3 mg/kg/day in two divided doses, titrated according to response, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Structured Behavioral Therapy | Other | Participants received structured behavioral therapy including patient education, lifestyle guidance, and maintenance of a headache diary, without pharmacological prophylaxis. Receives: Behavioral: Structured Behavioral Therapy |
| Propranolol | Experimental | Participants received oral propranolol at 1-3 mg/kg/day in two divided doses for 12 weeks. Dose titration was performed based on clinical response and tolerance. Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Change in PedMIDAS score from baseline to 12 weeks, assessing migraine-related disability in pediatric patients. The PedMIDAS score ranges from 0 to 240, with higher scores indicating greater migraine-related disability. Lower scores reflect less disability and therefore a better outcome.
Measured: Baseline and Week 12
Change in Visual Analog Scale (VAS) Pain Score
Change in VAS pain intensity score from baseline to 12 weeks, evaluating migraine pain severity. The VAS score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain severity, while lower scores indicate improvement.
Measured: Baseline and Week 12
Secondary outcomes (1)
Responder Rate
Proportion of participants achieving ≥50% reduction in monthly migraine frequency compared with baseline.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 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
- NCT07180043
- Sponsor's protocol ID
- KayseriUniversity
- Other IDs
- EC/IRB Number
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baykan M, Didinmez Taskirdi E, Baykan Copuroglu O, Gencpinar P, Olgac Dundar N. Clinical predictors of propranolol responsiveness in pediatric migraine: a prospective observational study. J Oral Facial Pain Headache. 2026 Mar;40(2):112-119. doi: 10.22514/jofph.2026.026. Epub 2026 Mar 12.
PubMed 41914064
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors of Propranolol Responsiveness in Pediatric Migraine: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07180043
- Acronym / sponsor ID
- KayseriUniversity
- Conditions
- Pediatric Migraine, Headache Disorders
- Keywords
- Pediatric Migraine, Propranolol, Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kayseri UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Sep 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 prospective, controlled clinical trial was conducted to evaluate the effectiveness of propranolol compared with structured behavioral therapy in pediatric patients diagnosed with primary migraine according to ICHD-3 criteria. A total of 178 children aged 6 to 16 years were enrolled between January 2021 and December 2023 at a tertiary pediatric neurology center.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores: Group 1 received standardized behavioral therapy, while Group 2 received propranolol at doses ranging from 1-3 mg/kg/day for 12 weeks. Primary outcomes included changes in PedMIDAS and Visual Analog Scale (VAS) scores. Secondary analyses investigated clinical and biochemical predictors of propranolol responsiveness, including benign paroxysmal vertigo, essential tremor, anxiety, vitamin D status, and vitamin B12 levels.
The study aims to provide evidence for a more personalized approach to migraine prophylaxis in children by integrating clinical, psychiatric, and nutritional predictors of treatment response.
Detailed description
Migraine is among the most common neurological disorders in children and adolescents, often leading to significant disability, reduced school performance, and impaired quality of life. Although propranolol is frequently prescribed for pediatric migraine prophylaxis, previous studies have reported heterogeneous outcomes, and clinical predictors of treatment response remain unclear.
This prospective, controlled clinical trial was designed to assess the comparative effectiveness of propranolol and structured behavioral therapy in pediatric migraine patients and to identify predictors of response to propranolol. A total of 178 children, aged 6-16 years, diagnosed with primary migraine according to ICHD-3 criteria, were consecutively recruited at a tertiary pediatric neurology center between January 2021 and December 2023.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores:
Group 1 (n = 88) received structured behavioral therapy, including patient education, lifestyle guidance, and headache diary maintenance.
Group 2 (n = 90) received oral propranolol at doses of 1-3 mg/kg/day for 12 weeks, with adherence monitored through logs and follow-up calls.
The primary outcomes were changes in PedMIDAS and Visual Analog Scale (VAS) scores after 12 weeks. Secondary outcomes included identification of clinical, psychiatric, and biochemical predictors of treatment responsiveness. Particular attention was given to benign paroxysmal vertigo, essential tremor, anxiety traits, and micronutrient deficiencies (vitamin D and vitamin B12).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Behavioral Therapy | Other | Behavioral: Structured Behavioral TherapyParticipants received structured behavioral therapy including patient education, lifestyle guidance, and maintenance of a headache diary, without pharmacological prophylaxis. |
| Propranolol | Experimental | Drug: PropranololParticipants received oral propranolol at 1-3 mg/kg/day in two divided doses for 12 weeks. Dose titration was performed based on clinical response and tolerance. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of primary migraine (with or without aura) according to ICHD-3 criteria
- Age between 6 and 16 years
- Minimum of 4 migraine attacks per month
- No history of prophylactic migraine therapy within the last 3 months
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- Secondary headaches due to underlying pathologies (e.g., tumors, infections, vascular malformations)
- Chronic systemic or psychiatric disorders (e.g., epilepsy, major depression)
- Contraindications to propranolol (e.g., asthma, cardiac conduction defects)
- Incomplete clinical data or loss to follow-up
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 |
|---|---|---|
| Structured Behavioral TherapyStructured patient education, lifestyle modification counseling, and headache diary maintenance without pharmacological prophylaxis. | Behavioural | Structured Behavioral Therapy |
| PropranololOral propranolol, 1-3 mg/kg/day in two divided doses, titrated according to response, for 12 weeks. | Drug | Propranolol |
Primary outcome
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time frame: Baseline and Week 12
Change in PedMIDAS score from baseline to 12 weeks, assessing migraine-related disability in pediatric patients. The PedMIDAS score ranges from 0 to 240, with higher scores indicating greater migraine-related disability. Lower scores reflect less disability and therefore a better outcome.
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline and Week 12
Change in VAS pain intensity score from baseline to 12 weeks, evaluating migraine pain severity. The VAS score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain severity, while lower scores indicate improvement.
1 secondary outcome
Responder Rate
Time frame: Week 12
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 18 Sep 2025.
- Derived from this study: PubMed 41914064Baykan M, Didinmez Taskirdi E, Baykan Copuroglu O, Gencpinar P, Olgac Dundar N. Clinical predictors of propranolol responsiveness in pediatric migraine: a prospective observational study. J Oral Facial Pain Headache. 2026 Mar;40(2):112-119. doi: 10.22514/jofph.2026.026. Epub 2026 Mar 12.
- 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?
A study testing Structured Behavioral Therapy and Propranolol in people with Pediatric Migraine and Headache Disorders, 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 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: finished, as of the sponsor's last update on 18 Sep 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?
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (time frame: Baseline and Week 12). 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?
On the ClinicalTrials.gov record for NCT07180043, which also lists 1 linked publication.
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 18 Sep 2025.