- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07755514
Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain
5 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
75
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Tamer Tamdogan, MD
- Numero di telefono: 0905065449917
- Email: tamer.tamdogan@giresun.edu.tr
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Serum NLRP3 Concentration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Neuropathic Pain Intensity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 agosto 2026
Completamento primario (Stimato)
30 settembre 2026
Completamento dello studio (Stimato)
15 ottobre 2026
Date di iscrizione allo studio
Primo inviato
5 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 agosto 2026
Primo Inserito (Effettivo)
10 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Nevralgia
- Aminoacidi, peptidi e proteine
- Prodotti chimici organici
- Idrocarburi
- Ciclohexanes
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Acidi, aciclici
- Acidi carbossilici
- Ammine
- Aminoacidi
- acido gamma-aminobutirrico
- Aminobutyrites
- Butirati
- Acidi, carbociclico
- Acidi cicloesanecarbossilici
- Gabapentin
- Pregabalin
Altri numeri di identificazione dello studio
- PREGABA-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .