Phase 1 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the 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 or older.
• People who are willing to sign a written consent form to take part in the study.
• People who are able to arrange their own transport to the study site every day for the full length of the study.
• People who have had a spinal cord injury (SCI) — either caused by a physical accident (traumatic) or by a medical condition (non-traumatic) — with neuropathic pain (nerve pain) that meets specific criteria: for traumatic or complete non-traumatic SCI, the injury must be at the T6 level or below and have lasted at least 12 months; for incomplete non-traumatic SCI caused by conditions such as disc degeneration, spinal stenosis, or spondylosis, the injury and associated nerve pain must have lasted at least 12 months (confirm with trial site for full details).
• People whose average daily nerve pain score, recorded over at least 6 out of 7 days using an 11-point scale, falls between 4 and 9, with scores that are fairly consistent day to day.
• People who have already tried at least 2 different types of medication for their nerve pain (such as antidepressants, anti-seizure medications, opioids, anti-inflammatories, or topical treatments) without sufficient relief.
• People who are in overall stable health, as determined by medical history, physical examination, blood tests, and heart tracing (ECG) results reviewed by the study team.
• People whose blood test results are normal or not significantly abnormal, including tests for kidney function, blood cell counts, and clotting, as assessed by the study investigator.
• People who test negative for HIV, Hepatitis B, and Hepatitis C within 30 days before being assigned to a treatment group.
• People whose hormone system tests (relating to the brain's control of stress hormones and reproductive hormones) come back normal (confirm with trial site for details).
• People who test negative for illicit drugs (marijuana/THC is permitted) and whose blood alcohol level is below 80 mg/dL at screening.
• Male participants who have not had a vasectomy, and their female partners, must agree to use contraception during the study and for 2 months after it ends.
• Male participants must agree not to donate sperm during the study and for 12 months after the last dose of the study drug.
• Female participants must not be pregnant or breastfeeding, and must either be postmenopausal for at least 1 year (confirmed by hormone testing), have had a surgical procedure making pregnancy impossible (such as tubal ligation or hysterectomy) for at least 3 months, or agree to use two highly effective non-hormonal forms of contraception (such as a copper or hormonal IUD combined with a barrier method like a condom or diaphragm) from 28 days before joining until 2 months after leaving the study; hormonal contraceptives (other than a hormonal IUD) are not permitted.
• People who can speak, read, and understand English well enough to complete all study activities.

Who may not be able to join:

• People who depend on a ventilator (breathing machine) to breathe, except those who only use CPAP or BiPAP at night for sleep.
• People whose pain is not present every day, or whose pain does not have the typical features of nerve pain.
• People who have other chronic nerve pain conditions, such as painful diabetic nerve pain, HIV-related nerve pain, or nerve pain caused by chemotherapy or alcohol use.
• People who have other pain conditions that might make it difficult to accurately assess their SCI-related nerve pain.
• People who only experience numbness without any spontaneous pain (either constant or occasional).
• People taking opioid pain medications at a dose higher than 60 morphine milligram equivalents (MME) per day, or at a dose that has not been stable for at least 4 weeks before joining.
• People with active Hepatitis A, B, or C infection.
• People with serious or unstable heart, kidney, liver, lung, digestive, blood, hormonal, or infectious diseases, including HIV, or who have had a heart attack within the past year.
• People with significantly abnormal vital signs, blood tests, or heart tracing (ECG) results, or people with very difficult-to-access veins for blood draws.
• People with a history of conditions affecting the brain's control of stress hormones or reproductive hormones, such as adrenal insufficiency, Cushing's syndrome, or low hormone levels (hypogonadism).
• People who have used steroid medications (topical, oral, or intravenous) within the past 12 weeks, or joint-injected steroids within the past 6 months, or who plan to use them during the study.
• People who have used fludrocortisone or testosterone products within the past 12 weeks, or who plan to use them during the study.
• People who have used, or plan to use during the study, certain blood pressure medications including ACE inhibitors, angiotensin receptor blockers (ARBs), direct renin inhibitors, or medications such as spironolactone or eplerenone, within 14 days of being assigned to a treatment group.
• People who have used chemotherapy, or who have a personal or close family history of cancer (other than fully removed non-spreading skin cancer) within the past 5 years.
• People who have needed antibiotics, antifungal, or antiviral treatment for an infection within 1 month before being assigned to a treatment group.
• People who have used, or plan to use during the study, certain prescription or over-the-counter drugs that strongly affect how the body processes medications (known as moderate-to-strong CYP3A4 inducers or inhibitors), within 14 days of being assigned to a treatment group (confirm with trial site for a full list).
• People who have consumed, or plan to consume during the study, foods or supplements that strongly affect medication processing — for example, grapefruit juice — within 14 days of being assigned to a treatment group.
• People who have difficulty swallowing tablets or capsules.
• People with serious psychological or social difficulties, as assessed by the study investigator.
• People with significant cognitive difficulties, major psychiatric conditions, or any condition that could make it hard to follow the study requirements.
• People who test positive for drugs (other than THC in minimal social use, at the investigator's discretion) or have a blood alcohol level above 80 mg/dL at screening, or who have had a binge drinking episode within 1 week before being assigned to a treatment group.
• People who have taken part in another clinical drug trial within 1 month before joining (or longer, if the previous trial drug stays in the body for an extended time).
• People with a current or recent history of stomach or gut disorders (such as ulcers), or kidney, liver, or clotting problems within 1 month before joining.
• People with a family history of serious heart conditions, such as sudden death of a close family member or a heart attack in a close family member before age 50.
• People who have had confirmed or suspected COVID-19 within 30 days before being assigned to a treatment group.
• People who have received a COVID-19 vaccine within 30 days before being assigned to a treatment group, or who plan to receive one during the study.
• People with a spinal cord injury at the T6 level or higher who also have a history of neurogenic bladder (a bladder control condition caused by nerve damage).
• People with a confirmed history of, or episodes consistent with, autonomic dysreflexia (a sudden and potentially dangerous rise in blood pressure), as assessed by an experienced clinician.

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