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Nonsteroidal Anti-inflammatory Drug

Ibuprofen + Nifedipine for Post-Seizure Symptoms in Epilepsy

Phase 2
Recruiting
Led By Paolo Federico, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Frequent seizures (>1 per week)
Age > 16 yrs
Must not have
Any contraindication to ibuprofen or nifedipine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 - 40 days
Awards & highlights

Summary

This trial will see if ibuprofen or nifedipine can help with post-seizure issues like reduced blood flow to the brain and neurological problems.

Who is the study for?
This trial is for individuals over 16 years old with epilepsy who have more than one seizure per week and can complete cognitive tests. It's not suitable for those with multiple seizure zones, allergies to ibuprofen or nifedipine, recent use of certain inhibitors or blockers, or contraindications to brain imaging.Check my eligibility
What is being tested?
The study examines the effects of ibuprofen and nifedipine on blood flow and neurological function after seizures in epilepsy patients. Participants will be randomly assigned to receive either ibuprofen, nifedipine, or a placebo.See study design
What are the potential side effects?
Ibuprofen may cause stomach upset, bleeding risks, kidney problems, and allergic reactions. Nifedipine could lead to swelling in the legs, dizziness, flushing and heart-related issues like rapid heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience more than one seizure per week.
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I am older than 16 years.
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I can complete tests that measure my thinking skills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or cannot take ibuprofen or nifedipine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 - 40 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 - 40 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postictal blood flow
Secondary outcome measures
Negative affect
Neuropsychological performance - Dimensional Change Card Sort Test
Neuropsychological performance - Flanker Inhibitory Control and Attention Test
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NifedipineExperimental Treatment1 Intervention
Patients will receive nifedipine 10 mg po tid for 2 days, then 20 mg po tid, thereafter for at least five days prior to the first blood flow study. They will continue to receive nifedipine until the baseline study is obtained after the postictal study has been completed.
Group II: IbuprofenExperimental Treatment1 Intervention
Patients will receive ibuprofen 400 mg by mouth three times a day (po tid) for at least five days prior to the first blood flow study. They will continue to receive ibuprofen until the baseline study is obtained after the postictal study has been completed.
Group III: PlaceboPlacebo Group1 Intervention
Patients will receive placebo for at least five days prior to the first blood flow study. They will continue to receive placebo until the baseline study is obtained after the postictal study has been completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nifedipine
FDA approved
Ibuprofen
FDA approved

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
800 Previous Clinical Trials
875,080 Total Patients Enrolled
3 Trials studying Epilepsy
357 Patients Enrolled for Epilepsy
Paolo Federico, MD, PhDPrincipal InvestigatorUniversity of Calgary

Media Library

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03949478 — Phase 2
Epilepsy Research Study Groups: Placebo, Ibuprofen, Nifedipine
Epilepsy Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT03949478 — Phase 2
Ibuprofen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03949478 — Phase 2
~10 spots leftby Jan 2025
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