Oral caffeine to reduce pain during acute migraine attacks
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
This test will see if a single 200 mg oral caffeine tablet taken during an acute migraine can reduce pain for adults with episodic or chronic migraine with or without aura.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07022496 on ClinicalTrials.gov |
What this trial studies
Adults diagnosed with migraine by ICHD-3 criteria are given a 200 mg caffeine tablet extracted from green tea during an acute migraine attack and pain severity is measured using a visual analogue scale (VAS) before and after treatment. The protocol allows common acute migraine medications such as triptans, NSAIDs, or paracetamol as listed interventions and records responses alongside caffeine use. The study is conducted in the headache and neurology outpatient clinics at Ain Shams University and targets real-world clinic patients. The main outcome is change in VAS pain score following the caffeine dose.
Who should consider this trial
Good fit: Adults with episodic or chronic migraine, with or without aura, diagnosed according to ICHD-3 who can attend the Ain Shams University outpatient clinic are eligible.
Not a fit: Patients with cardiac dysrhythmia, hypertension, ischemic heart disease, active peptic ulcer disease, inflammatory bowel disease, certain psychiatric disorders, pregnancy or breastfeeding, renal or hepatic failure, sleep disorders, substance abuse, or those with secondary headache causes are excluded and unlikely to be appropriate or benefit from this intervention.
Why it matters
Potential benefit: If effective, a single 200 mg caffeine tablet could offer a simple, low-cost option to reduce pain during acute migraine attacks.
How similar studies have performed: Prior research has shown that caffeine can enhance analgesic effects when combined with pain relievers, but using a standalone 200 mg caffeine tablet from green tea to abort acute migraine is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients suffering from migraine with aura, migraine without aura, episodic, and chronic migraine according to ICHD-3 diagnosis will be legible for the study. Exclusion Criteria: 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
Where this trial is running
Cairo
- Ainshams university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Nourhan Nader Elguindy, Masters degree
- Email: nourhanelguindy@gmail.com
- Phone: 00201128215952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.