MigrainePhase 4NCT07022496
Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals
A Phase 4 study testing Caffeine (200 mg), triptans and NSAID (Nonsteroidal anti-inflammatory drugs) in people with Migraine and Migraine Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
Caffeine extracted from green tea to abort acute attack of Migraine Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Migraine Disease, Migraine Headache
- What is being tested?
- Caffeine (200 mg), triptans and NSAID (Nonsteroidal anti-inflammatory drugs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Apr 2023to Aug 2025
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from migraine with aura, migraine without aura, episodic, and chronic migraine according to ICHD-3 diagnosis will be legible for the study.
Who cannot join
- Patients who have history of any cardiac dysrhythmia, hypertension, ischemic heart disease, active peptic ulcer disease, inflammatory bowel disease, obsessive compulsive disorder, pregnancy, breast-feeding, renal failure, hepatic failure, sleep disorder, mental retardation, and history of substance abuse that prevent them from cooperating with us during the study Patients who had headache due to: Cluster headache, trigeminal neuralgia, glossopharyngeal neuralgia, headache secondary to trauma, cranial disorder, vascular disorder, infection, or mass lesion, will also be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams university
Cairo, 11769
Diaa Marzouk Abdelhamid, PhD, 00201200678440, Diaamarzouk@yahoo.com
About this study
Official title: Assessment of Oral Caffeine Intake in Reducing the Severity of Acute Migraine Attack Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals: A Randomized Controlled Trial
Caffeine extracted from green tea to abort acute attack of Migraine
Read the detailed description
Caffeine tablets extracted from green tea can be used as caffeinated drinks to decrease intensity of migraine attacks
- Conditions
- Migraine, Migraine Disease, Migraine Headache, Migraine Headache, With or Without Aura, Migraine, Acute
- Being tested
- Caffeine (200 mg), triptans, NSAID (Nonsteroidal anti-inflammatory drugs), Paracetamol (acetaminophen)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine (200 mg)Drug
caffeine tablets
triptansDrug
Sumatriptan
NSAID (Nonsteroidal anti-inflammatory drugs)Drug
Aspirin 250 mg, 81 mg, 75 mg
Paracetamol (acetaminophen)Drug
Paracetamol 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Caffeine group | Experimental | Caffeine group added to standard treatment Receives: Drug: Caffeine (200 mg); Drug: triptans; Drug: NSAID (Nonsteroidal anti-inflammatory drugs); Drug: Paracetamol (acetaminophen) |
| Control group | Active comparator | Standard treatment (NSAIDS, Triptans, or Acetaminophen) Receives: Drug: triptans; Drug: NSAID (Nonsteroidal anti-inflammatory drugs); Drug: Paracetamol (acetaminophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reduce the severity of migraine attack
using Visual analogue scale
Measured: Three years
Secondary outcomes (1)
To evaluate the effect of oral caffeine in reducing pain associated with acute migraine attacks among patients attending Headache Clinic, Ain Shams University hospital via Visual analogue scale
To assess the pain reduction through visual analogue scale
Measured: Three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start26 Apr 2023
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Nader, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022496
- Sponsor's protocol ID
- FMASU MD87/2023
- Status last verified
- Jun 2025
- First submitted
- 23 Dec 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Abstract
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Caffeine Intake in Reducing the Severity of Acute Migraine Attack Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07022496
- Acronym / sponsor ID
- FMASU MD87/2023
- Conditions
- Migraine, Migraine Disease, Migraine Headache, Migraine Headache, With or Without Aura, Migraine, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Jun 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.
Caffeine extracted from green tea to abort acute attack of Migraine
Detailed description
Caffeine tablets extracted from green tea can be used as caffeinated drinks to decrease intensity of migraine attacks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine group | Experimental | Drug: Caffeine (200 mg), Drug: triptans, Drug: NSAID (Nonsteroidal anti-inflammatory drugs), Drug: Paracetamol (acetaminophen)Caffeine group added to standard treatment |
| Control group | Active comparator | Drug: triptans, Drug: NSAID (Nonsteroidal anti-inflammatory drugs), Drug: Paracetamol (acetaminophen)Standard treatment (NSAIDS, Triptans, or Acetaminophen) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients suffering from migraine with aura, migraine without aura, episodic, and chronic migraine according to ICHD-3 diagnosis will be legible for the study.
Key exclusion criteria (1 listed)
- Patients who have history of any cardiac dysrhythmia, hypertension, ischemic heart disease, active peptic ulcer disease, inflammatory bowel disease, obsessive compulsive disorder, pregnancy, breast-feeding, renal failure, hepatic failure, sleep disorder, mental retardation, and history of substance abuse that prevent them from cooperating with us during the study Patients who had headache due to: Cluster headache, trigeminal neuralgia, glossopharyngeal neuralgia, headache secondary to trauma, cranial disorder, vascular disorder, infection, or mass lesion, will also be excluded
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 |
|---|---|---|
| Caffeine (200 mg)caffeine tablets | Drug | Caffeine group |
| triptansSumatriptan | Drug | Caffeine group, Control group |
| NSAID (Nonsteroidal anti-inflammatory drugs)Aspirin 250 mg, 81 mg, 75 mg | Drug | Caffeine group, Control group |
| Paracetamol (acetaminophen)Paracetamol 250 mg | Drug | Caffeine group, Control group |
Primary outcome
To reduce the severity of migraine attack
Time frame: Three years
using Visual analogue scale
1 secondary outcome
To evaluate the effect of oral caffeine in reducing pain associated with acute migraine attacks among patients attending Headache Clinic, Ain Shams University hospital via Visual analogue scale
Time frame: Three year
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 15 Jun 2025.
- Individual participant dataSharing planned: Yes. Abstract
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine (200 mg), triptans and NSAID (Nonsteroidal anti-inflammatory drugs) in people with Migraine and Migraine Disease, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Nourhan Nader Elguindy, Masters degree (00201128215952, nourhanelguindy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reduce the severity of migraine attack (time frame: Three years). 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 15 Jun 2025.