Treating Postictal Symptoms Using Ibuprofen and Nifedipine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

NCT01426971

Pain

WITHDRAWN PHASE3

Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache

NCT01172405

Headache

UNKNOWN PHASE3

Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack

NCT01230411

Episodic Migraine

COMPLETED PHASE4

Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

NCT01077973

Pain

COMPLETED PHASE3

Study of Ibuprofen Effects on Brain Function

NCT02507219

Major Depressive Disorder

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy Epilepsies, Partial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will study 90 subjects admitted to hospital for epilepsy investigations. We will randomly divide the patients into three treatment groups (30 patients each). They will receive either placebo, ibuprofen, or nifedipine while in hospital. We will then determine the effect of each of these treatments on the severity of hypoperfusion and neurological deficits that follows their seizures.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The UofC Clinical Research Unit, which has no contact with patients or clinicians, will prepare the concealed randomization schedule and the randomization tool. Our research pharmacy will prepare three identical tablets to be given to each subject. The participant, care provider, investigators, and outcomes assessors will be blinded to treatment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.

Ibuprofen

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 Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.

Nifedipine

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 Type EXPERIMENTAL

Nifedipine

Intervention Type DRUG

Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibuprofen

Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.

Intervention Type DRUG

Nifedipine

Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.

Intervention Type DRUG

Placebo

Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Advil headache & migraine extra strength; DIN 02467658 Adalat XL 20 mg, DIN 02237618 Adalat XL 30 mg, DIN 02155907

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 16 yrs, frequent seizures (\>1 per week) and cognitive ability sufficient to complete neuropsychological testing.

Exclusion Criteria

* multiple seizure onset zones, contraindications to CT or MR imaging, any contraindication to ibuprofen or nifedipine, as well as current or recent (\< 2 months) exposure COX-2 inhibitor or calcium channel blocker.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No