Phase 3 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 of any gender aged between 18 and 75 years old
• People who are able to understand the study, agree to take part, complete the required procedures, and attend all scheduled visits by signing an approved consent form
• People who have been diagnosed with nerve pain caused either by diabetes (type 1 or 2) — with blood sugar levels within a certain range, nerve pain symptoms lasting at least 6 months, and stable diabetes medication for at least 30 days — or by shingles (postherpetic neuralgia), with pain continuing for at least 3 months after the shingles rash appeared
• People whose nerve pain rates at 4 or higher on a pain scale of 0 (no pain) to 10 (worst possible pain), confirmed by recording daily pain scores in a diary over 7 days during the screening period
• People who cannot become pregnant (such as post-menopausal women or those who have had surgical sterilisation, or men who have had a vasectomy), OR people who could become pregnant and agree to use a reliable form of contraception during the study

Who may not be able to join:

• People who have other sources of pain unrelated to diabetic nerve damage or shingles nerve pain that could affect pain assessments
• People who have a skin condition in the affected area that could interfere with sensation testing or pain evaluation
• People who have previously had nerve surgery to treat their neuropathy
• People currently using, or who have used within the past 7 days, certain medications including nerve block treatments, opioids, benzodiazepines, muscle relaxants, capsaicin, local anaesthetics, memantine, certain anti-epileptic drugs (such as gabapentin, carbamazepine, or valproic acid), certain antidepressants, or medications that may be toxic to nerves
• People who have previously had no response to pregabalin or gabapentin, or who have had an allergic reaction to either of those medications
• People with a history of cancer in the past 2 years (other than a specific type of skin cancer called basal cell carcinoma), neurological disease, unstable heart disease, certain psychiatric conditions (particularly thoughts of suicide), or infection with hepatitis B, hepatitis C, or HIV
• People with current abnormal liver enzyme results or reduced kidney function based on recent laboratory tests
• People with a history of illicit drug use in the past 2 years
• People with a history of heavy alcohol use in the past 2 years (above defined daily and weekly limits, which differ for men and women — confirm with trial site)
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study
• People who have taken part in another clinical trial within the past 12 months, unless the trial investigator determines there may be a direct benefit to the person
• People who have any other condition that the investigator believes would prevent safe participation in the study

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