Phase 3 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 willing to participate voluntarily and sign a consent form agreeing to all trial purposes
• People aged 18 years or older
• People who have been diagnosed with type 1 or type 2 diabetes for at least one year
• People whose diabetes medication has not changed in the past 3 months
• People who have been diagnosed with painful diabetic nerve damage affecting movement and sensation (sensorimotor diabetic polyneuropathy)
• People experiencing at least one of the following: numbness in the toes, feet, and/or legs; or tingling, pins and needles, or nerve pain in the toes, feet, and/or legs
• People showing at least one of the following on examination: reduced ability to feel touch, temperature, or pain in the lower legs; or reduced or absent Achilles tendon reflexes (ankle reflexes)
• People whose glycated hemoglobin (a blood sugar marker) is 11% or below
• People who score 12 points or more on a specific neuropathic pain assessment scale called the LANSS
• People with moderate to severe pain, scoring 4 or more out of 10 on a standard pain scale
• People with moderate to severe nerve pain who recorded pain on at least 4 out of 7 days during the baseline assessment period

Who may not be able to join:

• People with a known allergy or sensitivity to any ingredient used in the trial
• People with a history of alcohol or substance misuse within the past 2 years
• People who are pregnant, breastfeeding, planning to become pregnant, or people capable of becoming pregnant who are not using a reliable form of contraception
• People with a history of pernicious anaemia, uncontrolled underactive thyroid, or chronic hepatitis B
• People diagnosed with HIV
• People with a neurological condition unrelated to diabetic nerve damage
• People who have previously tried pregabalin (a nerve pain medication) and did not respond to it
• People whose recorded baseline pain scores vary too much to be reliably measured (confirm with trial site)
• People with other conditions that could affect sensation in the areas being assessed for nerve pain, which might make pain assessment unreliable
• People with a severe psychiatric condition
• People with cognitive difficulties that would affect their ability to accurately complete the trial's questionnaires and scales
• People with significant heart abnormalities that, in the treating doctor's judgement, would make participation risky
• People who have had a lower limb amputation due to diabetes complications
• People with kidney failure, defined as an eGFR (a measure of kidney function) below 60 mL/min/1.73m²

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