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 aged 18 or older, of any gender, who are expected to live for at least 5 more months
• People who have a confirmed diagnosis of a head or neck tumour that was treated with radiotherapy at least 6 months before the screening period
• People who have had ongoing nerve pain for at least 4 weeks in areas connected to where they received radiotherapy (such as the head, face, neck, or arms), confirmed by two trained nerve specialists using a recognised assessment tool
• People whose pain has averaged a score of 4 or higher (on a scale of 0–10) over 7 days during the screening period
• People who are able to understand and sign a written consent form, and who have the thinking and communication skills needed to complete study questionnaires

Who may not be able to join:

• People with severely abnormal blood counts, such as very low levels of certain white blood cells, platelets, or red blood cells
• People with severely abnormal liver function test results, or abnormal kidney function (including those currently on dialysis)
• People with elevated levels of a muscle enzyme called creatine kinase beyond a certain threshold
• People with serious heart or lung conditions, such as unstable chest pain, recent heart attack, severe irregular heartbeat, advanced heart failure, uncontrolled high blood pressure, or recurring asthma
• People with ongoing digestive conditions such as liver scarring, recurring stomach problems, or stomach ulcers
• People with neurological or mental health conditions that could affect pain assessment, such as epilepsy, recurring dizziness, memory or thinking problems, or a stroke or mini-stroke within the past 6 months
• People with a known allergy to the study drug or closely related medications
• People whose cancer has returned or spread, where that is causing their pain
• People whose nerve pain is caused by something other than radiotherapy (such as shingles, diabetes, HIV, spinal cord injury, or other nerve conditions)
• People who have used pregabalin or crisugabalin in the 4 weeks before screening
• People who previously took high doses of pregabalin (300 mg/day or more) or gabapentin (1,200 mg/day or more) and found them to be ineffective
• People who are pregnant, planning to become pregnant during the study, or breastfeeding
• People (or their partners) who are not willing to use reliable contraception from the time of consent until 28 days after the last dose of the study medication
• People who have taken part in another clinical trial within the 30 days before screening
• People who have taken certain other prohibited medications within a specific timeframe before screening (confirm with trial site)
• People the trial investigator considers unsuitable for any other reason

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