Comparing zonisamide and topiramate for migraine treatment
Safety and Efficacy of Zonisamide Versus Topiramate in Migraine
This study is testing whether zonisamide or topiramate is better at reducing the number of migraine days for people aged 10 to 55.
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 | NCT06347497 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of zonisamide versus topiramate in reducing the frequency of migraine days in patients diagnosed with migraines. A total of 600 participants aged 10 to 55 will be enrolled and divided into two groups, with one group receiving zonisamide and the other receiving topiramate, 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. Safety will also be monitored through regular follow-ups to document any treatment-emergent adverse events.
Who should consider this trial
Good fit: Ideal candidates for this study are migraine patients aged 10 to 55 who meet the ICHD3-beta criteria.
Not a fit: Patients with major neurological or systemic diseases, cardiovascular conditions, or contraindications to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from migraines.
How similar studies have performed: Previous studies have shown varying success with similar migraine treatments, but this specific comparison of zonisamide and topiramate is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 major systemic diseases such as malignancy, collagen, liver, and renal diseases. * Patients with cardiovascular diseases, such as hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions), diabetes (fasting plasma glucose level \>126 mg/dl and/or casual plasma glucose \>200 mg/dl), and/or HbA1C more than 6.5. * 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.