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RECRUITING
NCT06596681
EARLY_PHASE1

A Study of the Safety and Tolerability of GA in the Treatment of Patients With Refractory Neuropathic Pain

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

Previous studies have shown that the anterior cingulate cortex is involved in the regulation of pain and its associated negative emotions, that pyramidal neurons are highly excitable in chronic neuropathic pain conditions, and that silencing of pyramidal neurons can eliminate pain. The aim of this study was to evaluate the safety, tolerability, and efficacy of intracranial injection of GA (containing the hM4Di gene) in the anterior cingulate cortex in combination with oral clozapine for the treatment of refractory neuropathic pain.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-09-11

Completion Date

2026-06-30

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

GENETIC

GA+clozapine

Patients were first given intracranial injections of GA and observed for 14-28 days, followed by a dose-climbing trial of clozapine medication, and finally, after the investigators had determined an effective dose of clozapine, the patients were given a fixed dose of clozapine orally for three months.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China