Electrophysiologic Property of BrainPhase 1NCT02711579
Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer
A Phase 1 study testing Celecoxib in people with Electrophysiologic Property of Brain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrophysiologic Property of Brain
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to 28 Apr 2017
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female aged between 20 and 50 years.
- Signed voluntary written informed consent.
- Body mass index between 16.0 and 30.0 kg/m2.
Who cannot join
- History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
- History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
- History of any kind of medication(s) within 1 week before screening.
- Presence of clinically significant electrocardiogram abnormality at screening.
- aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
- Serum creatinine levels : greater than 1.5 × upper normal limit.
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- Platelet counts lower than 100,000 / μL
- Serum potassium : greater than 5.5 mmol/L
- Female who is pregnant, breastfeeding, or intends to become pregnant.
- History of noncompliance with medications.
- History of alcohol abuse.
- Participation in drug study within 30 days before screening.
- Galactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Selective Cyclooxygenase-2 Inhibitor, Celecoxib on Cortical Excitability and Electrophysiological Property in Brain of Healthy Volunteer: Randomized, Double-blind, Placebo-controlled Study
the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
Read the detailed description
Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.
In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.
- Conditions
- Electrophysiologic Property of Brain
- Being tested
- Celecoxib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib for electroencephalography | Experimental | Electroencephalography will be performed before and after celecoxib administration Receives: Drug: Celecoxib |
| Placebo for electroencephalography | Placebo comparator | Electroencephalography will be performed before and after placebo administration Receives: Drug: Placebo |
| Celecoxib for motor evoked potential | Experimental | Motor evoked potential will be measured before and after celecoxib administration Receives: Drug: Celecoxib |
| Placebo for motor evoked potential | Placebo comparator | Motor evoked potential will be measured before and after placebo administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer
Power spectrum will be measured by electroencephalography
Measured: 4 hours after medical treatment
Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
Cortical excitability will be measured by transmagnetic stimulation
Measured: 7 days after medical treatment
Secondary outcomes (1)
Power spectral change by celecoxib in different locations and different frequency band.
Power spectrum will be measured by electroencephalography
Measured: 4 hours and 7 days after medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrophysiologic Property of BrainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyung-Il Park, MD., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711579
- Sponsor's protocol ID
- H-1509-130-708
- Status last verified
- Dec 2016
- First submitted
- 8 Mar 2016
- Last updated
- 22 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Selective Cyclooxygenase-2 Inhibitor, Celecoxib on Cortical Excitability and Electrophysiological Property in Brain of Healthy Volunteer: Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02711579
- Acronym / sponsor ID
- H-1509-130-708
- Conditions
- Electrophysiologic Property of Brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 17 Mar 2016 (estimated)
- 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.
the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
Detailed description
Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.
In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celecoxib for electroencephalography | Experimental | Drug: CelecoxibElectroencephalography will be performed before and after celecoxib administration |
| Placebo for electroencephalography | Placebo comparator | Drug: PlaceboElectroencephalography will be performed before and after placebo administration |
| Celecoxib for motor evoked potential | Experimental | Drug: CelecoxibMotor evoked potential will be measured before and after celecoxib administration |
| Placebo for motor evoked potential | Placebo comparator | Drug: PlaceboMotor evoked potential will be measured before and after placebo administration |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female aged between 20 and 50 years.
- Signed voluntary written informed consent.
- Body mass index between 16.0 and 30.0 kg/m2.
Key exclusion criteria (13 listed)
- History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
- History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
- History of any kind of medication(s) within 1 week before screening.
- Presence of clinically significant electrocardiogram abnormality at screening.
- aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
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 |
|---|---|---|
| Celecoxib | Drug | Celecoxib for electroencephalography, Celecoxib for motor evoked potential |
| Placebo | Drug | Placebo for electroencephalography, Placebo for motor evoked potential |
Primary outcome
Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer
Time frame: 4 hours after medical treatment
Power spectrum will be measured by electroencephalography
Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
Time frame: 7 days after medical treatment
Cortical excitability will be measured by transmagnetic stimulation
1 secondary outcome
Power spectral change by celecoxib in different locations and different frequency band.
Time frame: 4 hours and 7 days after medical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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.
Kyung-Il Park, MD., PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib in people with Electrophysiologic Property of Brain, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer (time frame: 4 hours after medical treatment). The study lists 2 primary outcomes in all. 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 22 May 2017.