NCT03949478

Treating Postictal Symptoms Using Ibuprofen and Nifedipine

An Initial Clinical Study to Treat Postictal Symptoms

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy
• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	Ibuprofen	Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.
DRUG	Nifedipine	Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.
DRUG	Placebo	Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2019-05-14
• Last updated: 2024-05-09

Locations

2 sites across 1 country: Canada