Comparing lacosamide and topiramate for migraine treatment
Lacosamide Versus Topiramate in Migraine, a Ranodmized Trial
This study is testing whether lacosamide 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 | NCT06243692 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of lacosamide versus topiramate in reducing the frequency of migraine days in patients diagnosed with migraine disorders. A total of 600 participants aged 10-55 will be enrolled and divided into two groups: one receiving lacosamide and the other receiving topiramate, both in conjunction with acetaminophen for acute attacks. The study will assess the absolute reduction in monthly migraine days and the percentage of patients achieving a significant reduction in headache frequency after three months of treatment. 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 are naive migraine patients aged 10-55 who meet the ICHD3-beta criteria.
Not a fit: Patients with major neurological or systemic diseases, cardiovascular issues, or contraindications to the study drugs 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 lacosamide and topiramate is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 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 like 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 a 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 topiramate or lacosamide contraindications
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.