- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07755514
Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain
5. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
75
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Tamer Tamdogan, MD
- Telefonnummer: 0905065449917
- E-Mail: tamer.tamdogan@giresun.edu.tr
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Serum NLRP3 Concentration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Neuropathic Pain Intensity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. August 2026
Primärer Abschluss (Geschätzt)
30. September 2026
Studienabschluss (Geschätzt)
15. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
5. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. August 2026
Zuerst gepostet (Tatsächlich)
10. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Neuromuskuläre Erkrankungen
- Erkrankungen des peripheren Nervensystems
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Neuralgie
- Aminosäuren, Peptide und Proteine
- Organische Chemikalien
- Kohlenwasserstoffe
- Cyclohexane
- Cycloparaffine
- Kohlenwasserstoffe, alicyclisch
- Kohlenwasserstoffe, zyklisch
- Säuren, acyclisch
- Carboxylsäuren
- Amine
- Aminosäuren
- Gamma-Aminobuttersäure
- Aminobutyate
- Butyate
- Säuren, carbocyclisch
- Cyclohexanecarboxylsäuren
- Gabapentin
- Pregabalin
Andere Studien-ID-Nummern
- PREGABA-2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .