Phase 2 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:

• Adults aged 18 to 75 years who have been diagnosed with chronic neuropathic pain (nerve pain) in the arms or legs that has lasted longer than 3 months.
• People whose nerve pain scores 4 or higher on a specific 10-question nerve pain screening tool used at the first appointment.
• People who are able to read and write English well enough to complete study-related tasks.
• People with a body weight between 50 kg and 120 kg (110–264 pounds) and a body mass index (a measure of weight relative to height) between 18 and 35.
• People whose blood pressure, measured after lying down for about 5 minutes, falls within a specific range (90–145 mmHg systolic, no higher than 90 mmHg diastolic).
• People whose heart tracing (ECG) shows no significant problems, and whose heart's electrical timing measurement (QTc interval) is 450 milliseconds or less.
• People with a resting heart rate between 45 and 100 beats per minute.
• People whose standard blood test results and liver function tests are within normal ranges, or if slightly outside normal, considered not medically significant by the study doctor.
• People who agree to give written consent and follow the study rules around alcohol, caffeine, and tobacco or nicotine use during the study.
• People who are currently taking regular or as-needed medications for their chronic nerve pain and are willing to continue their regular medications throughout the study.

Who may not be able to join:

• People suspected of having raised pressure inside the skull or eyes.
• People who have previously received ketamine as a treatment for any chronic pain condition.
• People who have taken part in another clinical trial involving an experimental drug, device, or biological treatment within the past 30 days.
• People with serious medical conditions affecting the liver, heart, lungs, kidneys, blood, hormones, digestive system, immune system, skin, nervous system, cancer, or mental health, where the study doctor believes participation could be unsafe.
• People who have had a significant illness in the 2 weeks before the study drug is given.
• People who are unable to communicate effectively with the research team.
• People with a known liver disease.
• People with widespread pain throughout the body or a diagnosis of fibromyalgia.
• People currently diagnosed with a mental illness.
• People who are pregnant.
• People with a known allergy to ketamine or any other study drug.
• People who have consumed alcohol, grapefruit, poppy seeds, Brussels sprouts, pomegranate, broccoli, or char-grilled meat within 2 days before the study drug is given.
• People who have used tobacco or nicotine-containing products within 4 weeks before the study drug is given.
• People with poor vein access in the arms or hands.
• People the study doctor considers should not participate, for any reason.

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