MigrainePhase 3NCT07147972
Comparative Study of Nutraceuticals vs. Conventional Prophylactic Therapy in the Management of Migraine
A Phase 3 study testing Propranolol 80 mg and Magnesium 400Mg in people with Migraine and Nutraceuticals, run by Fayoum University.
Trial summary
Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Nutraceuticals
- What is being tested?
- Propranolol 80 mg and Magnesium 400Mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 1 Feb 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-60 years
- - Diagnosed with episodic migraine (ICHD-3 criteria)
- - ≥4 migraine attacks/month for the past 3 months
- - Willing to provide informed consent
Who cannot join
- • - Chronic migraine (>15 headache days/month)
- - Use of other prophylactic treatments in past month
- - History of secondary headaches
- - Pregnancy or breastfeeding
- - Significant renal, hepatic, or cardiac disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Recent evidence suggests that nutraceuticals like magnesium, riboflavin, and coenzyme Q10 may provide a safer alternative. This study aims to compare the efficacy and tolerability of these two approaches.
Read the detailed description
Primary Objective:
- To compare the reduction in the frequency of migraine attacks between patients receiving conventional prophylactic therapy and those receiving a nutraceutical combination.
Secondary Objectives:
- To evaluate changes in migraine intensity (VAS score), duration, and MIDAS score.
- To assess the side effect profile and patient satisfaction with both interventions.
- Conditions
- Migraine, Nutraceuticals
- Being tested
- Propranolol 80 mg, Magnesium 400Mg
- Keywords
- Migraine, Nutraceuticals
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol 80 mgDrug
Propranolol 40-80 mg/day
Magnesium 400MgDrug
Magnesium 400 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Conventional Therapy Receives: Drug: Propranolol 80 mg |
| Group 2 | Placebo comparator | Nutraceutical Therapy Receives: Drug: Magnesium 400Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
migraine intensity using The visual analog scale (VAS score)
To evaluate changes in migraine intensity using the visual analog scale (VAS score) in both groups which is one of the pain rating scales. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
Measured: 3 months
migraine duration
To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better.
Measured: 3 months
MIDAS score (Migraine Disability Assessment) Score
To evaluate changes in MIDAS score (Migraine Disability Assessment) in both groups. Which is a validated, 5-item questionnaire designed to quantify the severity of headache-related disability over the past three months by assessing missed days and reduced productivity in work/school, household chores, and social/family activities. The total score, which can range from 0 to 270, indicates the overall impact of migraines on daily functioning, with higher scores signifying greater disability. MIDAS score. Disability. MIDAS grade ; 0-5. Little or no disability. I ; 6-10. Mild disability. II ; 11-20. Moderate disability.
Measured: 3 months
Secondary outcomes (3)
changes in the frequency of migraine attacks
Number of participants with the change in the frequency of migraine attacks. Less frequency, the better.
Measured: 3 months
side effect profile
To calculate the % of patients who didn't experience side effects of treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction.
Measured: 3 months
patient satisfaction
To calculate the % of patients who were satisfied with the treatment in both interventions using a combination of standardized patient-reported outcome measures (PROMs) like the Treatment Satisfaction Questionnaire for Medication (TSQM) and SATMED-Q, alongside structured side effect symptom scales such as the Numerical Opioid Side Effect (NOSE) survey. I will Collect patient data through self-administered questionnaires and direct interviews, then analyze the frequency, intensity, and impact of adverse effects on daily life to evaluate satisfaction.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
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 MigraineStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Kamal Tolba, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147972
- Sponsor's protocol ID
- Management of Migraine
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charles A. The pathophysiology of migraine: implications for clinical management. Lancet Neurol. 2018 Feb;17(2):174-182. doi: 10.1016/S1474-4422(17)30435-0. Epub 2017 Dec 8.
PubMed 29229375
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Nutraceuticals vs. Conventional Prophylactic Therapy in the Management of Migraine
- ClinicalTrials.gov ID
- NCT07147972
- Acronym / sponsor ID
- Management of Migraine
- Conditions
- Migraine, Nutraceuticals
- Keywords
- Migraine, Nutraceuticals
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 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.
Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Recent evidence suggests that nutraceuticals like magnesium, riboflavin, and coenzyme Q10 may provide a safer alternative. This study aims to compare the efficacy and tolerability of these two approaches.
Detailed description
Primary Objective:
- To compare the reduction in the frequency of migraine attacks between patients receiving conventional prophylactic therapy and those receiving a nutraceutical combination.
Secondary Objectives:
- To evaluate changes in migraine intensity (VAS score), duration, and MIDAS score.
- To assess the side effect profile and patient satisfaction with both interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Propranolol 80 mgConventional Therapy |
| Group 2 | Placebo comparator | Drug: Magnesium 400MgNutraceutical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years
Key exclusion criteria (5 listed)
- • - Chronic migraine (>15 headache days/month)
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 |
|---|---|---|
| Propranolol 80 mgPropranolol 40-80 mg/day | Drug | Group 1 |
| Magnesium 400MgMagnesium 400 mg daily | Drug | Group 2 |
Primary outcome
migraine intensity using The visual analog scale (VAS score)
Time frame: 3 months
To evaluate changes in migraine intensity using the visual analog scale (VAS score) in both groups which is one of the pain rating scales. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
migraine duration
Time frame: 3 months
To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better.
MIDAS score (Migraine Disability Assessment) Score
Time frame: 3 months
To evaluate changes in MIDAS score (Migraine Disability Assessment) in both groups. Which is a validated, 5-item questionnaire designed to quantify the severity of headache-related disability over the past three months by assessing missed days and reduced productivity in work/school, household chores, and social/family activities. The total score, which can range from 0 to 270, indicates the overall impact of migraines on daily functioning, with higher scores signifying greater disability. MIDAS score. Disability. MIDAS grade ; 0-5. Little or no disability. I ; 6-10. Mild disability. II ; 11-20. Moderate disability.
3 secondary outcomes
changes in the frequency of migraine attacks
Time frame: 3 months
side effect profile
Time frame: 3 months
patient satisfaction
Time frame: 3 months
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 29 Aug 2025.
- Background: PubMed 29229375Charles A. The pathophysiology of migraine: implications for clinical management. Lancet Neurol. 2018 Feb;17(2):174-182. doi: 10.1016/S1474-4422(17)30435-0. Epub 2017 Dec 8.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propranolol 80 mg and Magnesium 400Mg in people with Migraine and Nutraceuticals, run by Fayoum University.
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 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: opening soon, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Marwa Kamal Tolba, Associate professor (01067789982, mka05@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
migraine intensity using The visual analog scale (VAS score) (time frame: 3 months). The study lists 3 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 NCT07147972, 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 29 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.