Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

Phase 1

Completed

• Conditions: Electrophysiologic Property of Brain
• Interventions: Drug: Placebo; Drug: Celecoxib

• Registration Number: NCT02711579
• Lead Sponsor: Seoul National University Hospital

Brief 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

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 Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2016-05
• Status Verified: 2016-12
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for electroencephalography	Placebo	Electroencephalography will be performed before and after placebo administration
Placebo for motor evoked potential	Placebo	Motor evoked potential will be measured before and after placebo administration
Celecoxib for electroencephalography	Celecoxib	Electroencephalography will be performed before and after celecoxib administration
Celecoxib for motor evoked potential	Celecoxib	Motor evoked potential will be measured before and after celecoxib administration

Primary Outcome Measures

Name	Time	Method
Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer	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	7 days after medical treatment	Cortical excitability will be measured by transmagnetic stimulation

Secondary Outcome Measures

Name	Time	Method
Power spectral change by celecoxib in different locations and different frequency band.	4 hours and 7 days after medical treatment	Power spectrum will be measured by electroencephalography

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of