Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 11/30/2016 |
| Primer enviat: | 03/07/2016 |
| Inscripció estimada enviada: | 03/10/2016 |
| Publicat per primera vegada: | 03/16/2016 |
| Última actualització enviada: | 05/17/2017 |
| Publicació de l'última actualització: | 05/21/2017 |
| Data d'inici de l'estudi real: | 04/30/2016 |
| Data estimada de finalització primària: | 04/27/2017 |
| Data estimada de finalització de l’estudi: | 04/27/2017 |
Condició o malaltia
Intervenció / tractament
Drug: Celecoxib
Drug: Placebo
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Celecoxib for electroencephalography Electroencephalography will be performed before and after celecoxib administration | |
| Placebo Comparator: Placebo for electroencephalography Electroencephalography will be performed before and after placebo administration | |
| Experimental: Celecoxib for motor evoked potential Motor evoked potential will be measured before and after celecoxib administration | |
| Placebo Comparator: Placebo for motor evoked potential Motor evoked potential will be measured before and after placebo administration |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 20 Years Per a 20 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer [4 hours after medical treatment]
2. 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]
Mesures de resultats secundaris
1. Power spectral change by celecoxib in different locations and different frequency band. [4 hours and 7 days after medical treatment]
