RecruitingEarly Phase 1NCT06596681

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


Sponsor

Beijing Tiantan Hospital

Enrollment

6 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying GA+clozapine for people with pain, intractable. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICGA+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

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NCT06596681


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