Treating Postictal Symptoms Using Ibuprofen and Nifedipine

Last updated: May 8, 2024
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

2

Condition

Epilepsy

Treatment

Nifedipine

Placebo

Ibuprofen

Clinical Study ID

NCT03949478
TPS-1.0
  • Ages > 16
  • All Genders

Study Summary

This study will evaluate the effect of ibuprofen or nifedipine on post-seizure hypoperfusion and neurological deficits in patients with epilepsy. One group will receive ibuprofen, another will receive nifedipine, and anther placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 16 yrs, frequent seizures (>1 per week) and cognitive ability sufficient tocomplete neuropsychological testing.

Exclusion

Exclusion Criteria:

  • multiple seizure onset zones, contraindications to CT or MR imaging, anycontraindication to ibuprofen or nifedipine, as well as current or recent (< 2 months)exposure COX-2 inhibitor or calcium channel blocker.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Nifedipine
Phase: 2
Study Start date:
February 01, 2021
Estimated Completion Date:
March 01, 2025

Study Description

Immediately following seizures, brain blood flow is significantly reduced for approximately one hour and is located to the brain area where the seizure originated. This may contribute to symptoms that patients experience immediately following seizures and in between seizures.

Animal studies have shown that that giving anti-inflammatory drugs (e.g., ibuprofen) and blood pressure medications (e.g., nifedipine) prevents the hypoperfusion and behavioural impairments seen in animals immediately following seizures. Thus, two classes of inexpensive and well-tolerated drugs - already in clinical use - have been identified that can be tested in humans to prevent the serious consequences that follow seizures.

The investigators will study 90 subjects admitted to hospital for epilepsy investigations. The investigators will randomly divide the patients into three treatment groups (30 patients each). Patients will receive either placebo, ibuprofen, or nifedipine while in hospital. The effect of each of these treatments on the severity of hypoperfusion and neurological deficits that follows seizures will then be assessed.

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta T2N T29
    Canada

    Active - Recruiting

  • South Health Campus

    Calgary, Alberta T3M 1M4
    Canada

    Active - Recruiting

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