Using ibuprofen and nifedipine to treat symptoms after seizures
An Initial Clinical Study to Treat Postictal Symptoms
This study is testing whether ibuprofen and nifedipine can help people with epilepsy feel better after seizures by improving blood flow to the brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT03949478 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of ibuprofen and nifedipine on post-seizure symptoms in patients with epilepsy. Following seizures, blood flow to the brain is significantly reduced, which may lead to neurological deficits. The study will involve 90 subjects who will be randomly assigned to receive either ibuprofen, nifedipine, or a placebo. The goal is to determine if these medications can prevent the negative consequences of reduced blood flow after seizures.
Who should consider this trial
Good fit: Ideal candidates are individuals over 16 years old with frequent seizures occurring more than once a week.
Not a fit: Patients with multiple seizure onset zones or contraindications to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved management of postictal symptoms in epilepsy patients.
How similar studies have performed: Animal studies have shown promising results with similar approaches, but this is a novel application in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 16 yrs, frequent seizures (\>1 per week) and cognitive ability sufficient to complete neuropsychological testing. Exclusion Criteria: * multiple seizure onset zones, contraindications to CT or MR imaging, any contraindication to ibuprofen or nifedipine, as well as current or recent (\< 2 months) exposure COX-2 inhibitor or calcium channel blocker.
Where this trial is running
Calgary, Alberta and 1 other locations
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- South Health Campus — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Paolo Federico, MD, PhD — University of Calgary
- Study coordinator: Paolo Federico, MD, PhD
- Email: pfederic@ucalgary.ca
- Phone: =1.403.944.4091
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.