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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 - 40 days

Awards & highlights

Study 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.

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,064 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you discuss other experiments conducted with Ibuprofen?

"At present, there are 53 studies examining the efficacy of Ibuprofen in operation. 13 of these trials have progressed to Phase 3 and 173 medical sites across the country have opened their doors for participation. Most notably, Pittsburgh Pennsylvania is a hub for investigations into this drug."

Answered by AI

What risks have been associated with Ibuprofen consumption?

"Our team at Power assessed Ibuprofen's safety with a score of 2, indicating that there is some empirical data demonstrating its security but no proof of efficacy yet."

Answered by AI

Is there availability for participants in this clinical experiment?

"Clinicaltrials.gov currently states that this medical trial is open for enrollment, with the initial posting having occurred on February 1st 2021 and a recent edit occurring November 15th 2022."

Answered by AI

Is this a pioneering clinical trial?

"Clinicialtrials.gov has identified 53 live studies with Ibuprofen across 92 cities and 17 nations, beginning in 2007 when Encysive Pharmaceuticals conducted a Phase 2 drug approval involving 27 participants. Since then, 18675 have been completed successfully."

Answered by AI

What conditions does Ibuprofen commonly address?

"Ibuprofen is the most popular treatment for catarrh, and it can also assist with muscle spasms, early labor, and pulmonary hypertension."

Answered by AI

How many patients have signed up for participation in this medical experiment?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is currently enrolling participants, with the first post being made on February 1st 2021 and last edited on November 15th 2022. 90 patients need to be enrolled from two distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treating Postictal Symptoms Using Ibuprofen and Nifedipine

2021. "Treating Postictal Symptoms Using Ibuprofen and Nifedipine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03949478.

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