Clinical trial NCT03949478: Treating Postictal Symptoms Using Ibuprofen and Nifedipine
Official title: An Initial Clinical Study to Treat Postictal Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Epilepsy
Epilepsies, Partial
Keywords: Postictal
Blood flow
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postictal blood flow
timeFrame: 5 - 40 days
Secondary outcomes:
measure: Neuropsychological performance - Picture Sequence Memory Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance - Flanker Inhibitory Control and Attention Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance - List Sorting Working Memory Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance - Picture Vocabulary Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance- Oral Reading Recognition Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance - Dimensional Change Card Sort Test
timeFrame: 5 - 40 days
measure: Neuropsychological performance - Pattern Comparison Processing Speed Test
timeFrame: 5 - 40 days
measure: Psychological well-being
timeFrame: 5 - 40 days
measure: Social Relationships
timeFrame: 5 - 40 days
measure: Stress and Self-Efficacy Relationships
timeFrame: 5 - 40 days
measure: Negative affect
timeFrame: 5 - 40 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Paolo Federico, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: