EpilepsyPhase 2NCT03949478
Treating Postictal Symptoms Using Ibuprofen and Nifedipine
A Phase 2 study testing Ibuprofen and Nifedipine in people with Epilepsy and Epilepsies, Partial, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Epilepsies, Partial
- What is being tested?
- Ibuprofen and Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2021to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 16 yrs, frequent seizures (>1 per week) and cognitive ability sufficient to complete neuropsychological testing.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N T29
Paolo Federico, MD, PhD, +1.403.944.4091, pfederic@ucalgary.ca
- Recruiting
South Health Campus
Calgary, Alberta, T3M 1M4
Paolo Federico, MD, PhD, 403.944.4091, pfederic@ucalgary.ca
About this study
Official title: An Initial Clinical Study to Treat Postictal Symptoms
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.
Read the 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.
- Conditions
- Epilepsy, Epilepsies, Partial
- Being tested
- Ibuprofen, Nifedipine, Placebo
- Keywords
- Postictal, Blood flow
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil headache & migraine extra strength; DIN 02467658
Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.
NifedipineDrug
Also called Adalat XL 20 mg, DIN 02237618, Adalat XL 30 mg, DIN 02155907
Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.
PlaceboDrug
Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postictal blood flow
Change in cerebral blood flow following seizures, relative to baseline. It will be measured by CT perfusion or ASL MRI.
Measured: 5 - 40 days
Secondary outcomes (11)
Neuropsychological performance - Picture Sequence Memory Test
For all Cognition Domain tests, three standardized scores are provided:
- An uncorrected score comparing the test-taker to all individuals in the NIH Toolbox normative sample (mean = 100, SD = 15);
- An age-corrected score that compares the test-taker to NIH Toolbox age-matched individuals (mean = 100, standard deviation = 15); and
- A fully-corrected T-score that adjusts for key demographic variables including age, sex, race/ethnicity, and educational attainment (mean = 50, standard deviation = 10).
Measure = Picture sequence memory Construct = Episodic memory
Scale ranges:
- uncorrected score (mean = 100, SD = 15).
- age-corrected score (mean = 100, SD = 15).
- fully-corrected T-score (mean = 50, SD = 10). For this test, a greater standardized score indicates better episodic memory.
Measured: 5 - 40 days
Neuropsychological performance - Flanker Inhibitory Control and Attention Test
Measure = Flanker Inhibitory Control and Attention Test Construct = Executive Function \& Attention
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a higher raw or standardized score indicates greater inhibitory control and attention.
Measured: 5 - 40 days
Neuropsychological performance - List Sorting Working Memory Test
Measure = List Sorting Working Memory Test Construct = Working Memory
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a greater raw or standardized score indicates better episodic memory.
Measured: 5 - 40 days
Neuropsychological performance - Picture Vocabulary Test
Measure = Picture Vocabulary Test Construct = Language
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a higher standardized score indicates greater general vocabulary knowledge.
Measured: 5 - 40 days
Neuropsychological performance- Oral Reading Recognition Test
Measure = Oral Reading Recognition Test Construct = Language
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a higher standardized score indicates a greater ability to read aloud.
Measured: 5 - 40 days
Neuropsychological performance - Dimensional Change Card Sort Test
Measure = Dimensional Change Card Sort Test Construct = Executive function
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a greater raw or standardized score indicates greater cognitive flexibility.
Measured: 5 - 40 days
Neuropsychological performance - Pattern Comparison Processing Speed Test
Measure = Pattern Comparison Processing Speed Test Construct = Processing Speed
Scale ranges:
- uncorrected score (mean = 100, standard deviation = 15). Higher score is better
- age-corrected score (mean = 100, standard deviation = 15). Higher score is better.
- fully-corrected T-score (mean = 50, standard deviation = 10). Higher score is better.
For this test, a greater raw or standardized score indicates faster processing speed.
Measured: 5 - 40 days
Psychological well-being
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.
Measured: 5 - 40 days
Social Relationships
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.
Measured: 5 - 40 days
Stress and Self-Efficacy Relationships
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.
Measured: 5 - 40 days
Negative affect
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.
Measured: 5 - 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Feb 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Federico, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949478
- Sponsor's protocol ID
- TPS-1.0
- Status last verified
- May 2024
- First submitted
- 11 Apr 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Clinical Study to Treat Postictal Symptoms
- ClinicalTrials.gov ID
- NCT03949478
- Acronym / sponsor ID
- TPS-1.0
- Conditions
- Epilepsy, Epilepsies, Partial
- Keywords
- Postictal, Blood flow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients 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. |
| Ibuprofen | Experimental | Drug: IbuprofenPatients 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. |
| Nifedipine | Experimental | Drug: NifedipinePatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- age > 16 yrs, frequent seizures (>1 per week) and cognitive ability sufficient to complete neuropsychological testing.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Advil headache & migraine extra strength; DIN 02467658Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet. | Drug | Ibuprofen |
| NifedipineAlso: Adalat XL 20 mg, DIN 02237618, Adalat XL 30 mg, DIN 02155907Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet. | Drug | Nifedipine |
| PlaceboSugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet. | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Neuropsychological performance - Picture Sequence Memory Test
Time frame: 5 - 40 days
Neuropsychological performance - Flanker Inhibitory Control and Attention Test
Time frame: 5 - 40 days
Neuropsychological performance - List Sorting Working Memory Test
Time frame: 5 - 40 days
Neuropsychological performance - Picture Vocabulary Test
Time frame: 5 - 40 days
Neuropsychological performance- Oral Reading Recognition Test
Time frame: 5 - 40 days
Neuropsychological performance - Dimensional Change Card Sort Test
Time frame: 5 - 40 days
Neuropsychological performance - Pattern Comparison Processing Speed Test
Time frame: 5 - 40 days
Psychological well-being
Time frame: 5 - 40 days
Social Relationships
Time frame: 5 - 40 days
Stress and Self-Efficacy Relationships
Time frame: 5 - 40 days
Negative affect
Time frame: 5 - 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Federico, MD, PhD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen and Nifedipine in people with Epilepsy and Epilepsies, Partial, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Federico, MD, PhD (=1.403.944.4091, pfederic@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postictal blood flow (time frame: 5 - 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.