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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 - 40 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postictal blood flow

Secondary study objectives

Negative affect

Neuropsychological performance - Dimensional Change Card Sort Test

Neuropsychological performance - Flanker Inhibitory Control and Attention Test

+8 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 4Eligibility criteria met