- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949478
Treating Postictal Symptoms Using Ibuprofen and Nifedipine
An Initial Clinical Study to Treat Postictal Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Paolo Federico, MD, PhD
- Phone Number: =1.403.944.4091
- Email: pfederic@ucalgary.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N T29
- Recruiting
- Foothills Medical Centre
-
Contact:
- Paolo Federico, MD, PhD
- Phone Number: +1.403.944.4091
- Email: pfederic@ucalgary.ca
-
Calgary, Alberta, Canada, T3M 1M4
- Recruiting
- South Health Campus
-
Contact:
- Paolo Federico, MD, PhD
- Phone Number: 403.944.4091
- Email: pfederic@ucalgary.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.
|
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.
|
Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.
Other Names:
|
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.
|
Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postictal blood flow
Time Frame: 5 - 40 days
|
Change in cerebral blood flow following seizures, relative to baseline.
It will be measured by CT perfusion or ASL MRI.
|
5 - 40 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological performance - Picture Sequence Memory Test
Time Frame: 5 - 40 days
|
For all Cognition Domain tests, three standardized scores are provided:
Measure = Picture sequence memory Construct = Episodic memory Scale ranges:
|
5 - 40 days
|
Neuropsychological performance - Flanker Inhibitory Control and Attention Test
Time Frame: 5 - 40 days
|
Measure = Flanker Inhibitory Control and Attention Test Construct = Executive Function & Attention Scale ranges:
For this test, a higher raw or standardized score indicates greater inhibitory control and attention. |
5 - 40 days
|
Neuropsychological performance - List Sorting Working Memory Test
Time Frame: 5 - 40 days
|
Measure = List Sorting Working Memory Test Construct = Working Memory Scale ranges:
For this test, a greater raw or standardized score indicates better episodic memory. |
5 - 40 days
|
Neuropsychological performance - Picture Vocabulary Test
Time Frame: 5 - 40 days
|
Measure = Picture Vocabulary Test Construct = Language Scale ranges:
For this test, a higher standardized score indicates greater general vocabulary knowledge. |
5 - 40 days
|
Neuropsychological performance- Oral Reading Recognition Test
Time Frame: 5 - 40 days
|
Measure = Oral Reading Recognition Test Construct = Language Scale ranges:
For this test, a higher standardized score indicates a greater ability to read aloud. |
5 - 40 days
|
Neuropsychological performance - Dimensional Change Card Sort Test
Time Frame: 5 - 40 days
|
Measure = Dimensional Change Card Sort Test Construct = Executive function Scale ranges:
For this test, a greater raw or standardized score indicates greater cognitive flexibility. |
5 - 40 days
|
Neuropsychological performance - Pattern Comparison Processing Speed Test
Time Frame: 5 - 40 days
|
Measure = Pattern Comparison Processing Speed Test Construct = Processing Speed Scale ranges:
For this test, a greater raw or standardized score indicates faster processing speed. |
5 - 40 days
|
Psychological well-being
Time Frame: 5 - 40 days
|
The Psychological Well-Being measure assesses a subjective and experiential aspect of pleasure and positive affect, as well as fulfillment and purpose. Psychological Well-being composite scores are generated as the weighted average of the uncorrected standardized score (T scores; mean = 50, SD = 10) obtained from each subdomain: Positive Affect Construct = This portion assesses positive affect, or feelings of a pleasurable engagement with the environment, using a positive affect survey. Higher scores = more positive affect. Life Satisfaction Construct = This portion assesses how the participant evaluates their life, in terms of whether they like it or not, using a life satisfaction survey. Higher scores = greater life satisfaction. Meaning and Purpose Construct = This portion evaluates the degree to which the participant feels their life matters or makes sense. Higher scores = greater sense of meaning and purpose. |
5 - 40 days
|
Social Relationships
Time Frame: 5 - 40 days
|
The Social Relationships measure assesses the participants social network structure, extent, and quality. Composite social satisfaction composite scores are generated as the weighted average of the T-scores (mean = 50, SD = 10) from the subdomains, with loneliness and perceived rejection reverse-coded. Perceived Social Support Construct = This portion evaluates the degree to which the participant feels their life matters or makes sense. Higher scores = greater sense of meaning and purpose. Companionship Construct = This portion assesses self-reported perceptions of the participant has companions to interact with and perceptions of being alone or lonely. Higher scores = higher perceived friendship or more loneliness. Social Distress Construct = This portion evaluates the degree to which the participant feels their life matters or makes sense. Higher scores = greater perceived hostility and rejection. |
5 - 40 days
|
Stress and Self-Efficacy Relationships
Time Frame: 5 - 40 days
|
The Stress and Self-Efficacy measure assesses the individual's perception of life events and their relationships as well as their perceived coping skills. Stress and self-efficacy composite scores are generated as the weighted average of the T-scores (mean = 50, SD = 10) from the subdomains Perceived Stress Construct = This portion evaluates the participants perceived stress. Higher scores = greater perceived stress. Self-Efficacy Construct = This portion assesses self-efficacy, or the participants belief in their capacity to manage and have control over events. Higher scores = more general self-efficacy. |
5 - 40 days
|
Negative affect
Time Frame: 5 - 40 days
|
composite scores are generated as the weighted average of the T-scores from the subdomains. Negative affect includes the following subdomains: Anger Construct = This portion assesses attitudes of hostility and cynicism. Higher scores = higher levels of anger. Fear Construct = This portion assesses the participants perception of threat and autonomic arousal associated with fear. Higher scores = higher levels of fear. Sadness Construct = This portion assesses the participants feelings of sadness, or their low levels of positive affect or low mood. Higher scores = more sadness. |
5 - 40 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Federico, MD, PhD, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Epilepsies, Partial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Ibuprofen
- Nifedipine
Other Study ID Numbers
- TPS-1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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