Comparing zonisamide and propranolol for migraine treatment
Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial
This study is testing whether zonisamide or propranolol is better at reducing the number of migraine days for people who suffer from migraines.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 10 Years to 55 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr Ash Shaykh) |
| Trial ID | NCT06361446 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of zonisamide and propranolol in reducing the frequency of migraine days in patients diagnosed with migraines. A total of 600 participants will be enrolled and divided into two groups: one receiving zonisamide and the other receiving propranolol, both for a duration of three months. The study will assess the absolute reduction in monthly migraine days and the percentage of patients achieving a significant reduction in headache frequency. Additionally, safety will be monitored through the documentation of any treatment-emergent adverse events.
Who should consider this trial
Good fit: Ideal candidates are naive migraine patients aged 10 to 55 years who meet the ICHD3-beta criteria.
Not a fit: Patients with major neurological disorders, malignancies, or significant cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for migraine patients.
How similar studies have performed: Previous studies have shown varying success with similar migraine treatments, but this specific comparison of zonisamide and propranolol is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, * age from 10 to 55 years Exclusion Criteria: Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors. patients with malignancy, collagen, liver, and renal diseases. patients with cardiovascular diseases like hypertension and diabetes patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease
Where this trial is running
Kafr Ash Shaykh
- Kafr Elsheikh University Hospital — Kafr Ash Shaykh, Egypt (Recruiting)
Study contacts
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
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.