Recruiting
Phase 2

Ibuprofen & Nifedipine

Sponsor:

University of Calgary

Code:

NCT03949478

Conditions

Epilepsy

Epilepsies, Partial

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Nifedipine

Placebo

Study Details

Brief summary:

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.

Conditions

Epilepsy

Epilepsies, Partial

Study ID

NCT03949478

Start date

Feb 1, 2021

Status verified date

May, 2024

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: 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.

experimental: 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.

experimental: 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.

Interventions

Ibuprofen

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

Nifedipine

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

Placebo

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

Primary outcome measure

  • Postictal blood flow [ Time Frame: 5 - 40 days ]

Central Contacts and Locations

Central contacts

Paolo Federico, MD, PhD

=1.403.944.4091pfederic@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N T29

Contacts

Paolo Federico, MD, PhD

+1.403.944.4091pfederic@ucalgary.ca

South Health Campus

Recruiting

Calgary, Alberta, Canada, T3M 1M4

Contacts

Paolo Federico, MD, PhD

403.944.4091pfederic@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 9, 2024

Last verified

May, 2024

Keywords

  • Postictal
  • Blood flow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-05-09.