- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07755514
Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain
keskiviikko 5. elokuuta 2026 päivittänyt: Tamer Tamdogan, Giresun University
Translational Analysis of Changes in Inflammatory Biomarkers and Subclinical Cardiac Function Associated With Gabapentin and Pregabalin Use in Patients With Peripheral Neuropathic Pain: A Prospective Controlled Cohort Study
This prospective, controlled, observational cohort study will evaluate short-term changes in inflammatory biomarkers and subclinical cardiac function in adults with peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care.
A total of 75 participants will be enrolled: 25 patients starting gabapentin, 25 patients starting pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain.
Treatment selection and dose adjustments will be determined by the treating physician and will not be assigned by the study investigators.
Participants will be assessed at baseline and again after 30 ± 7 days.
Assessments will include clinical information, pain severity, routine laboratory results, inflammatory biomarkers, and standard transthoracic echocardiography.
No additional blood will be collected solely for research; leftover serum from routine testing will be used.
The primary aim is to compare changes over time between the gabapentin and pregabalin groups, while the healthy control group will provide a reference for interpretation.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Yksityiskohtainen kuvaus
Peripheral neuropathic pain is a chronic condition associated with a lesion or disease of the somatosensory nervous system.
Neuroimmune and inflammatory mechanisms may contribute to its development and persistence.
Gabapentin and pregabalin are alpha-2-delta ligands commonly prescribed for neuropathic pain; however, whether these medications are associated with different short-term changes in inflammatory pathways and early cardiac function remains unclear.This is a single-center, prospective, controlled, observational cohort study with repeated measurements.
A total of 75 adults will be enrolled in three groups: 25 patients with peripheral neuropathic pain who are prescribed gabapentin, 25 patients with peripheral neuropathic pain who are prescribed pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain.The decision to initiate gabapentin or pregabalin, including the selected drug, starting dose, dose adjustment, continuation, or discontinuation, will be made by the treating neurosurgery physician as part of routine clinical care and independently of study participation.
The investigators will not randomize participants, assign treatment, determine medication doses, or modify routine treatment decisions.Patients in the gabapentin and pregabalin cohorts will undergo baseline assessment before the first medication dose and a follow-up assessment 30 ± 7 days later.
Healthy controls will undergo corresponding assessments at enrollment and after 30 ± 7 days.
Clinical assessments will include demographic characteristics, neuropathic pain characteristics, pain severity measured using a 0-10 numerical rating scale, comorbidities, concomitant medications, blood pressure, heart rate, medication exposure, adherence, treatment tolerability, and adverse events.Routine laboratory findings will be recorded.
No additional blood sample will be collected solely for research purposes.
After completion of clinically required laboratory testing, leftover serum will be coded, aliquoted, stored at -80 °C, and used to measure the inflammatory and signaling biomarkers NLRP3, nuclear factor kappa B p65 (NF-κB p65), and signal transducer and activator of transcription 3 (STAT3), according to the manufacturers' instructions.Standard transthoracic echocardiography will be performed by a cardiologist at baseline and follow-up.
Echocardiographic assessments will include left ventricular ejection fraction, left ventricular global longitudinal strain, left ventricular dimensions and wall thickness, left atrial volume index, transmitral E/A ratio, tissue Doppler e' velocity, E/e' ratio, tricuspid annular plane systolic excursion, right ventricular S' velocity, and other clinically relevant standard measurements.The primary objective is to compare changes from baseline to 30 ± 7 days in inflammatory biomarkers and subclinical cardiac function between the gabapentin and pregabalin cohorts.
The primary analysis will assess the group-by-time interaction using a linear mixed-effects model.
The healthy control cohort will serve as a reference group for secondary and exploratory comparisons.
Additional analyses will examine associations among biomarker changes, pain severity, cardiac function, clinical characteristics, medication exposure, and treatment tolerability.De-identified clinical findings may also be integrated with publicly available, anonymous transcriptomic or genomic summary datasets for exploratory, hypothesis-generating translational analyses.
No genomic sequencing will be performed on study participants, and biological samples will not be transferred outside the study institution.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
75
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Tamer Tamdogan, MD
- Puhelinnumero: 0905065449917
- Sähköposti: tamer.tamdogan@giresun.edu.tr
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
The study population will consist of 75 adults recruited at a single center.
The patient population will include adults with clinically diagnosed peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care.
Eligible patients will be enrolled consecutively into the gabapentin cohort (n=25) or pregabalin cohort (n=25), according to the treatment selected by the treating physician independently of the study.The healthy control cohort will include 25 adults attending the cardiology outpatient clinic for a routine health examination or check-up who have no peripheral neuropathy, chronic neuropathic pain, current gabapentin or pregabalin use, or clinically significant cardiovascular disease.
Healthy controls will be frequency matched to the patient cohorts, as feasible, by age, sex, and body mass index.
Kuvaus
Inclusion Criteria:
- Patient Cohorts:Age 18 years or older.A clinical diagnosis of peripheral neuropathic pain based on medical history, physical and neurological examination, and, when available, electrophysiological testing or imaging.A determination, following routine clinical evaluation, that initiation of gabapentin or pregabalin is clinically appropriate.Ability to complete baseline assessments before the first dose.Ability and willingness to provide written informed consent.Healthy Controls:Age 18 years or older.Attendance at the cardiology department for a routine health examination or check-up.No peripheral neuropathy, chronic neuropathic pain, gabapentin or pregabalin use, or clinically significant cardiovascular disease based on standard clinical screening.Eligibility, as far as possible, for frequency matching with the patient cohorts by age, sex, and body mass index.Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Known or newly identified heart failure.2. Clinically significant valvular heart disease, cardiomyopathy, significant cardiac arrhythmia, previous acute coronary syndrome, or other significant structural heart disease.3. Active or recent acute infection.4. Active autoimmune or systemic inflammatory disease.5. Active malignancy.6. Recent major surgery, severe trauma, or acute cardiovascular event.7. Current systemic corticosteroid or immunosuppressive treatment.8. Advanced renal or hepatic dysfunction.9. Uncontrolled thyroid disease.10. Pregnancy or breastfeeding.11. Any acute clinical condition likely to substantially affect baseline biomarker measurements.12. Current use of gabapentin or pregabalin at baseline.13. Inability to complete baseline measurements before the first dose of gabapentin or pregabalin.14. Any other condition that, in the investigator's judgment, would prevent safe or appropriate participation in the study
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
Gabapentin Cohort
Adults with peripheral neuropathic pain who are prescribed gabapentin by the treating physician as part of routine clinical care, independently of study participation.
Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later.
The investigators will not assign the medication, determine the dose, or modify treatment decisions.
|
Gabapentin prescribed as part of routine clinical care for peripheral neuropathic pain.
The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation.
The study investigators will not assign or modify treatment.
|
|
Pregabalin Cohort
Adults with peripheral neuropathic pain who are prescribed pregabalin by the treating physician as part of routine clinical care, independently of study participation.
Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later.
The investigators will not assign the medication, determine the dose, or modify treatment decisions.
|
Pregabalin prescribed as part of routine clinical care for peripheral neuropathic pain.
The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation.
The study investigators will not assign or modify treatment.
|
|
Healthy Control Cohort
Adults without peripheral neuropathy or chronic neuropathic pain and without current gabapentin or pregabalin use.
Healthy controls will be frequency matched to the patient cohorts, as feasible, by age, sex, and body mass index.
Assessments will be performed at enrollment and again after 30 ± 7 days.
Participants in this cohort will not receive gabapentin or pregabalin as part of the study.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Serum NLRP3 Concentration
Aikaikkuna: Baseline and 30 ± 7 days after treatment initiation
|
Serum NLRP3 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Serum NF-κB p65 Concentration
Aikaikkuna: Baseline and 30 ± 7 days after treatment initiation
|
Serum nuclear factor kappa B p65 (NF-κB p65) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Serum STAT3 Concentration
Aikaikkuna: Baseline and 30 ± 7 days after treatment initiation
|
Serum signal transducer and activator of transcription 3 (STAT3) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Left Ventricular Global Longitudinal Strain
Aikaikkuna: Baseline and 30 ± 7 days after treatment initiation
|
Left ventricular global longitudinal strain (LV-GLS) will be assessed by standard transthoracic echocardiography and reported as a percentage.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit, using the same echocardiography system and analysis software whenever possible.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
|
Baseline and 30 ± 7 days after treatment initiation
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Neuropathic Pain Intensity
Aikaikkuna: Baseline and 30 ± 7 days after treatment initiation
|
Neuropathic pain intensity will be assessed in the gabapentin and pregabalin cohorts using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Change will be calculated as the follow-up score minus the baseline score
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Left Ventricular Ejection Fraction
Aikaikkuna: Baseline and 30 ± 7 days after baseline
|
Left ventricular ejection fraction will be measured by standard transthoracic echocardiography using the biplane Simpson method and reported as a percentage.
Change will be calculated as the follow-up value minus the baseline value.
|
Baseline and 30 ± 7 days after baseline
|
|
Change From Baseline in Left Atrial Volume Index
Aikaikkuna: Baseline and 30 ± 7 days after baseline
|
Tricuspid annular plane systolic excursion (TAPSE) will be measured by transthoracic echocardiography and reported in millimeters as an indicator of right ventricular systolic function.
Change will be calculated as the follow-up value minus the baseline value.
|
Baseline and 30 ± 7 days after baseline
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
- Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
- Fiore NT, Debs SR, Hayes JP, Duffy SS, Moalem-Taylor G. Pain-resolving immune mechanisms in neuropathic pain. Nat Rev Neurol. 2023 Apr;19(4):199-220. doi: 10.1038/s41582-023-00777-3. Epub 2023 Mar 1.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Lauantai 15. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Keskiviikko 30. syyskuuta 2026
Opintojen valmistuminen (Arvioitu)
Torstai 15. lokakuuta 2026
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 5. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 5. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Maanantai 10. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 10. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 5. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Kipu
- Neurologiset ilmenemismuodot
- Hermoston sairaudet
- Neuromuskulaariset sairaudet
- Ääreishermoston sairaudet
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Hermosärky
- Aminohapot, peptidit ja proteiinit
- Orgaaniset kemikaalit
- Hiilivety
- Sykloheksanit
- Sykloparaffiinit
- Hiilivedyt, aliisykliset
- Hiilivedyt, sykliset
- Hapot, asyklinen
- Karboksyylihapot
- Amiini
- Aminohapot
- gamma-aminobutyrinen happo
- Aminobutyraatit
- Butyraatit
- Hapot, karbosyklinen
- Sykloheksanikarboksyylihappot
- Gabapentiini
- Pregabaliini
Muut tutkimustunnusnumerot
- PREGABA-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
There is currently no plan to make individual participant-level data publicly available.
Study findings will be reported in aggregate and de-identified form.
Any sharing of de-identified data with authorized researchers will be subject to ethics committee approval, institutional policies, and applicable data protection requirements.
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