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 aged 18 or older at the time of the screening appointment
• People who have been diagnosed with Complex Regional Pain Syndrome Type 1 (CRPS-1) based on a recognised set of diagnostic guidelines, with no known nerve damage, and where symptoms affect only one limb (such as an arm, hand, wrist, leg, ankle, or foot) and that limb is noticeably different from the opposite limb
• People whose affected limb shows swelling, plus at least two of the following: visible redness compared to the other limb, a temperature at least 1°C warmer than the other limb, or moderate-to-severe swelling
• People whose CRPS symptoms started no more than 6 months before the randomisation appointment
• People whose bone scan (a specific type of imaging test) shows increased activity in the affected limb compared to the other limb, either done during screening or within the 3 months before the randomisation appointment
• Women who are able to become pregnant must not be pregnant, must not be breastfeeding, and must agree to use a highly effective form of contraception during the trial and for at least 6 months after the last dose of the study treatment (this does not apply to women who exclusively have same-sex sexual relationships)
• People who have consistently completed an electronic diary during the screening period

Who may not be able to join:

• People who have been diagnosed with CRPS Type 2, an unspecified form of CRPS, CRPS with no known triggering event, or CRPS-1 that does not show the "warm subtype" signs at screening
• People who score 40 or more on the Pain Catastrophizing Scale, which is a questionnaire about how a person thinks and feels about pain
• People who have previously used a medication called neridronate, or who have taken part in a clinical study where they may have received neridronate
• People who have received certain bone or immune-related medications within specific timeframes before the randomisation appointment — including intravenous bisphosphonates or intravenous immunoglobulin within the past 12 months, or oral bisphosphonates, denosumab, calcitonin, ketamine, or radiation therapy to the head or neck within the past 6 months
• People who are currently taking, or plan to take, medications or therapies that are not permitted during the trial, or who are unlikely to be able to follow the trial's rules about other treatments
• People with severely reduced kidney function
• People with low calcium levels in their blood
• People with vitamin D deficiency
• People with significant dental issues, such as a tooth extraction site that has not fully healed
• People with inflammation in their eyes
• People with significantly abnormal liver test results or evidence of serious liver disease
• People with unstable heart disease
• People who have any other condition, present from 3 months before screening through to the randomisation visit, that may affect the assessment of CRPS-1 symptoms, pain, safety, or other trial measurements (confirm with trial site)

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