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:

• People who are able to understand the study information and are willing to sign a consent form agreeing to take part.
• People who are 18 years of age or older, of any gender.
• People who have been diagnosed with postherpetic neuralgia (PHN) — meaning nerve pain that has continued for more than one month after a shingles rash has healed.
• People whose pain, measured using a standard pain rating scale in the 24 hours before their screening visit, scores 40 mm or higher out of 100 mm.

Who may not be able to join:

• People who have a known allergy to the study drug, the rescue medication, or similar medicines or their ingredients.
• People who have another nerve condition or source of pain not related to PHN (such as stroke, spinal problems, kidney disease, thyroid disease, or other causes) that the trial doctor thinks could make it harder to assess the PHN pain accurately.
• People who have certain serious ongoing health conditions that the trial doctor believes could interfere with participation or with measuring the treatment's effect, including:
  • Serious heart or lung problems, such as unstable chest pain, a heart attack or severe irregular heartbeat in the past 6 months, poorly controlled high blood pressure, or recurring asthma;
  • Ongoing digestive conditions such as liver scarring, chronic active hepatitis, or stomach ulcers;
  • Neurological or mental health conditions such as epilepsy, recurring dizziness or headaches, memory or thinking problems, a stroke or repeated mini-strokes in the past 6 months;
  • A history of cancer in the past 5 years (with some exceptions, such as certain treated skin cancers or early-stage thyroid cancer);
  • An active infection that the trial doctor considers makes participation unsuitable;
  • Diabetes with poorly managed blood sugar levels at the time of screening;
  • Conditions that weaken the immune system, such as lupus, HIV/AIDS, or use of immune-suppressing medicines.
• People whose skin in the affected area has a skin condition that the trial doctor believes could interfere with pain assessment.
• People who have previously had nerve-destroying procedures for their PHN pain, or who have had nerve blocks, nerve stimulation, physical therapy (such as red light therapy), or treatments such as acupuncture within one week before screening.
• People who have recently used certain prohibited medications, or who have changed the dose of certain restricted medications within the 14 days before screening (confirm with trial site for specific medicines).
• People whose blood test results at screening show significant problems with blood cell counts, liver function, kidney function, or a muscle enzyme called creatine kinase (confirm with trial site for specific values).
• People who have already been diagnosed with sleep apnoea, or who have severe snoring, daytime sleepiness, and episodes of low oxygen levels during sleep.
• People who have a history of suicidal behaviour, or who are assessed as having suicidal thoughts using a standard rating scale at screening.
• People whose screening blood tests show active hepatitis B, hepatitis C, HIV, or syphilis infection.
• People with a known history of drug misuse, or a history of heavy alcohol use (more than 14 standard drinks per week) in the year before screening.
• People who are pregnant or breastfeeding.
• People who are planning to have a child during the study period or within one month after the study ends, or who are unwilling to use at least one non-hormonal form of contraception (such as condoms or an intrauterine device) throughout the study.
• People who have taken part in another clinical drug trial within 30 days before screening.
• People whose work or daily activities during the study period involve working at heights, driving motor vehicles, or operating heavy machinery where there may be a safety risk.
• People who the trial doctor considers unsuitable for any other reason.

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