90 Participants Needed

Ibuprofen + Nifedipine for Post-Seizure Symptoms in Epilepsy

Recruiting at 1 trial location
PF
Overseen ByPaolo Federico, MD, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have taken a COX-2 inhibitor or calcium channel blocker in the last 2 months.

What safety data exists for using Ibuprofen and Nifedipine in treating post-seizure symptoms in epilepsy?

The safety data for Ibuprofen and Nifedipine in treating post-seizure symptoms in epilepsy is limited. Ibuprofen has been shown to have beneficial effects on seizures in animal studies, suggesting it can be used safely for epilepsy without inducing seizures. However, high doses of Ibuprofen can be lethal, as seen in rat studies. Nifedipine, a dihydropyridine derivative, has shown anticonvulsant activity in animal models, but its effects are less potent than other anticonvulsants like phenytoin and valproate. Overall, more clinical studies are needed to confirm the safety and efficacy of this combination for post-seizure symptoms in epilepsy.12345

Is the drug Ibuprofen, Nifedipine, Placebo a promising treatment for post-seizure symptoms in epilepsy?

Ibuprofen shows promise as a treatment for epilepsy because it can reduce seizures and protect brain cells, according to studies on rats. Nifedipine, however, has shown limited success in improving seizure control in humans.12678

What data supports the idea that Ibuprofen + Nifedipine for Post-Seizure Symptoms in Epilepsy is an effective drug?

The available research shows that ibuprofen alone has some beneficial effects on seizures in animal studies. For example, ibuprofen reduced seizure scores and protected brain cells in rats with induced epilepsy. It also enhanced the effectiveness of other epilepsy drugs in mice. However, there is no specific data on the combination of ibuprofen and nifedipine for post-seizure symptoms in epilepsy. The research on nifedipine alone is limited, with only a preliminary report on its use in a few patients with uncontrolled epilepsy. Therefore, while ibuprofen shows promise, more research is needed to confirm the effectiveness of the combination with nifedipine for this condition.12679

Who Is on the Research Team?

PF

Paolo Federico, MD, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I experience more than one seizure per week.
I am older than 16 years.
I can complete tests that measure my thinking skills.

Exclusion Criteria

I am allergic or cannot take ibuprofen or nifedipine.
I have taken COX-2 inhibitors or calcium channel blockers in the last 2 months.
You cannot have CT or MR imaging due to specific health reasons.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo, ibuprofen, or nifedipine for at least five days prior to the first blood flow study and continue until the baseline study is obtained after the postictal study has been completed

5-40 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ibuprofen
  • Nifedipine
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: NifedipineExperimental Treatment1 Intervention
Group II: IbuprofenExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:

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Approved in United States as Advil for:
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Approved in Canada as Motrin for:
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Approved in European Union as Nurofen for:
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Approved in Japan as Ibuprofen for:
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Approved in China as Ibuprofen for:
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Approved in Switzerland as Ibuprofen for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Published Research Related to This Trial

In a study involving conscious rats subjected to 20 sessions of pentylenetetrazol to induce seizures, pretreatment with paracetamol significantly reduced seizure activity, indicating its potential efficacy in managing seizure episodes.
While some NSAIDs like mefenamic acid showed varying effects on seizure activity, none of the pretreatments prevented the long-term development of seizure susceptibility, suggesting that while NSAIDs can influence immediate seizure responses, they do not alter the underlying process of epileptogenesis.
Attenuation of epileptogenesis by nonsteroidal anti-inflammatory drugs in the rat.Wallenstein, MC.[2019]
Nifedipine was used as an additional treatment for three patients with uncontrolled epilepsy, suggesting potential benefits in managing this condition.
The study highlights the exploration of nifedipine's role in epilepsy management, although specific outcomes and efficacy details are not provided in the abstract.
[Nifedipine as a coadjuvant drug in the treatment of uncontrolled epilepsy: a preliminary report].Rotta, NT., Ohlweiler, L., Lago, IS.[2019]
In a study involving 48 rats, ibuprofen was found to significantly reduce seizure activity induced by pentylenetetrazol, as evidenced by lower spike percentages and improved onset times for myoclonic jerks.
The research also indicated that ibuprofen administration led to lower levels of prostaglandin F2 alpha in the brain compared to control groups, suggesting a potential mechanism for its antiepileptic effects, while highlighting the need for further studies to confirm these findings.
Beneficial Effects of Ibuprofen on Pentylenetetrazol-induced Convulsion.Durankuş, F., Şenkal, E., Sünnetçi, E., et al.[2021]

Citations

Attenuation of epileptogenesis by nonsteroidal anti-inflammatory drugs in the rat. [2019]
[Nifedipine as a coadjuvant drug in the treatment of uncontrolled epilepsy: a preliminary report]. [2019]
Beneficial Effects of Ibuprofen on Pentylenetetrazol-induced Convulsion. [2021]
Ibuprofen Exerts Antiepileptic and Neuroprotective Effects in the Rat Model of Pentylenetetrazol-Induced Epilepsy via the COX-2/NLRP3/IL-18 Pathway. [2021]
Effect of non-steroidal anti-inflammatory drugs on the anticonvulsive activity of valproate and diphenylhydantoin against maximal electroshock-induced seizures in mice. [2015]
Evaluation of anticonvulsant effect of two novels 4-[1-(4-fluorobenzyl)- 5-imidazolyl] dihydropyridine derivatives in mice. [2021]
Hypokalaemia in ibuprofen and codeine phosphate abuse. [2020]
Lowering of the convulsive threshold by non-steroidal anti-inflammatory drugs. [2019]
Nifedipine as an add-on drug in the management of refractory epilepsy. [2019]
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