Treating Postictal Symptoms Using Ibuprofen and Nifedipine

NCT03949478 | Recruiting Phase 2 DMC

• 1 other identifier: TPS-1.0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Keywords

Postictal; Blood flow

Outcome Measures

Primary Outcomes (1)

• Postictal blood flow

  Change in cerebral blood flow following seizures, relative to baseline. It will be measured by CT perfusion or ASL MRI.

  5 - 40 days

Secondary Outcomes (11)

• Neuropsychological performance - Picture Sequence Memory Test

  5 - 40 days

• Neuropsychological performance - Flanker Inhibitory Control and Attention Test

  5 - 40 days

• Neuropsychological performance - List Sorting Working Memory Test

  5 - 40 days

• Neuropsychological performance - Picture Vocabulary Test

  5 - 40 days

• Neuropsychological performance- Oral Reading Recognition Test

  5 - 40 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Ibuprofen

EXPERIMENTAL

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.

Drug: Ibuprofen

Nifedipine

EXPERIMENTAL

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.

Drug: Nifedipine

Interventions

Ibuprofen DRUG

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

Also known as: Advil headache & migraine extra strength; DIN 02467658

Ibuprofen

Nifedipine DRUG

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

Also known as: Adalat XL 20 mg, DIN 02237618, Adalat XL 30 mg, DIN 02155907

Nifedipine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N T29, Canada

RECRUITING

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

RECRUITING

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Interventions

Ibuprofen; Nifedipine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paolo Federico, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Federico, MD, PhD

CONTACT

=1.403.944.4091; pfederic@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 14, 2019
• Study Start: February 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CA (2)