Early Phase 1 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old who have been formally diagnosed with a neuropathic pain condition (nerve pain), such as diabetic nerve pain, trigeminal neuralgia, or pain following a stroke
• People who have already tried standard treatments for their nerve pain — such as medications, physiotherapy, cognitive therapy, or nerve blocks — for at least 3 months without meaningful relief, or who have developed a tolerance to those treatments, as determined by the trial investigator
• People who have completed a full course of at least two first-line pain medications without adequate relief, as determined by the trial investigator
• People whose pain scores on standard rating scales average 4 or above (out of 10) in the week before enrolling in the trial
• People who have been on a stable pain management routine for at least 30 days before enrolling, and who agree not to change their medications during the trial assessment period
• People who agree to take part voluntarily and sign an informed consent form
• People whose nervous system is considered stable, based on tests of movement, sensation, and reflexes, as assessed by a researcher
• People who the investigator considers reliable and capable of following the trial procedures, attending visits, and completing relevant questionnaires
• People of childbearing potential who agree to use effective contraception (not including oral contraceptive pills) during the study and who do not plan to become pregnant or donate eggs or sperm during that time

Who may not be able to join:

• People with diabetic nerve pain who have had an amputation related to diabetes, or who have large (3 cm or bigger) or gangrenous ulcers on their lower limbs
• People currently diagnosed with a progressive neurological condition, such as multiple sclerosis, chronic inflammatory nerve disease, brain or spinal cord tumours, or neurodegenerative diseases, as determined by the investigator
• People with a serious ongoing illness that the investigator believes could affect their participation, including severe heart or lung disease (such as unstable angina, recent heart attack, severe irregular heartbeat, or recurring severe asthma), or cancer affecting the brain, nervous system, or other body systems
• People with blood clotting problems, bleeding tendencies, platelet dysfunction, severe heart or lung limitations, progressive vascular disease in the limbs, or poorly controlled diabetes that could affect surgical safety, as assessed by the investigator
• People currently taking blood-thinning medications (anticoagulants) who are unable to stop taking them
• People with an infection at the planned surgical site, or an active infection anywhere in the body
• People who have previously had brain surgery (not including minor diagnostic procedures such as a small needle aspiration)
• People with severe psychiatric conditions such as major depression or schizophrenia, significant thoughts of suicide, or whom the investigator believes cannot complete the trial
• People with severe liver, kidney, or heart problems; or those with delirium, very low blood pressure, epilepsy, glaucoma, severely reduced white blood cell counts, serious suppression of the central nervous system, or coma from any cause (confirm specific test thresholds with trial site)
• People whose blood test results fall outside certain ranges, including low white blood cell or neutrophil counts, low platelet levels, abnormal clotting test results, or high levels of a specific antibody to a virus used in gene therapy (AAV antibody titre above 1:1000) (confirm with trial site)
• People taking medications known to reduce white blood cell (granulocyte) counts or suppress bone marrow function
• People who have previously developed a severe lack of white blood cells (granulocyte deficiency) due to prior use of the medication clozapine
• People who are allergic or have a known sensitivity to clozapine, its components, contrast dyes used in imaging, or other medications used in the trial
• People with significant digestive tract diseases (such as Crohn's disease, pancreatitis, or intestinal obstruction) or who have had major gastrointestinal surgery that could affect how medications are absorbed or processed by the body
• People who have previously received any gene therapy or cell therapy
• People with a known history of alcohol or drug misuse
• People who have participated in another clinical trial or used another experimental treatment, drug, or device within the six months before screening
• People who cannot have MRI scans for any reason, such as claustrophobia or having metal objects in their body
• People who experience a serious adverse reaction to clozapine during the screening period, as determined by the investigator

Important: Always verify eligibility with the trial site directly before applying.