NCT04664530

The Study on the Esketamine in the Treatment of Postherpetic Neuralgia

Status unknown Phase 4 Last updated 11 December 2020

What this trial tests

Phase 4 trial testing esketamine in Postherpetic Neuralgia in 48 participants. Status unknown.

Timeline

25 November 2020

Primary endpoint
1 June 2022

1 December 2023

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	25 November 2020
Primary completion	1 June 2022
Estimated completion	1 December 2023
Sites	1 location across China

Drugs / interventions tested

• esketamine (ESKETAMINE) — full drug profile →
• Saline

Conditions studied

• Postherpetic Neuralgia — all drugs for Postherpetic Neuralgia →
• Esketamine — all drugs for Esketamine →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 80, any sex, with Postherpetic Neuralgia or Esketamine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Herpes zoster (HZ) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the sensory ganglia. Postherpetic neuralgia (PHN) often occurs after herpes zoster heals and persists for a long time. At present, clinically anticonvulsants (such as gabapentin, pregabalin) and antidepressants (such as amitriptyline) are clinically first-line drugs for the treatment of PHN, which are not usually effective to treat PHN well, as well as to alleviate patients' bad mental symptoms. Esketamine, as a well-known N-methyl-D-aspartate receptor inhibitor, has both analgesic and antidepressant effects with extremely few incidence of respiratory depression, delirium, hallucinations, nausea and vomiting. Therefore, we hypothesize that esketamine could relieve PHN and Anxiety and depression-like symptoms symptoms in patients with PHN. This study intended to compare the efficacy of pregabalin, amitriptyline combined with esketamine therapy and pregabalin combined with amitriptyline therapy for alleviating PHN, and to further explore the feasibility and safety of esketamine in the treatment of PHN as well as underlying the mechanism of esketamine on the PHN.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Investigational Drugs for the Treatment of Postherpetic Neuralgia: Systematic Review of Randomized Controlled Trials.
   Huerta MÁ, Garcia MM, García-Parra B, Serrano-Afonso A, et al · · 2023 · cited 20× · PMID 37629168 · DOI 10.3390/ijms241612987
2. Potential novel therapeutic strategies for neuropathic pain.
   Du Z, Zhang J, Han X, Yu W, et al · · 2023 · cited 15× · PMID 37152429 · DOI 10.3389/fnmol.2023.1138798