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 have voluntarily agreed to take part in this clinical trial.
• Men and women aged 19 years or older at the time of signing the consent form.
• People who have been genetically diagnosed with CMT type 1A (CMT1A).
• People whose CMT symptoms fall within a specific range on a standard nerve disease scoring scale called CMTNSv2, with a score between 2 and 20.
• People who experience muscle weakness related to difficulty lifting the front part of the foot (foot drop).
• People of childbearing potential who agree to use an approved form of contraception during the trial period, as outlined by the trial team. This includes hormonal contraceptives, intrauterine devices or systems, sterilisation procedures, a combination of two contraceptive methods, or complete abstinence from sexual intercourse (confirm with trial site for full details).

Who may not be able to join:

• People who have a neuromuscular disease other than CMT1A, or a condition such as kidney failure (uremia) that could affect the trial results, as determined by the investigator.
• People who have been diagnosed with type 1 or type 2 diabetes.
• People who have been diagnosed with active tuberculosis of the lungs.
• People with severely uncontrolled high blood pressure (top number above 180 mmHg or bottom number above 110 mmHg).
• People with other serious conditions affecting the heart, lungs, liver, kidneys, blood, immune system, mental health, or with a current cancer diagnosis, as determined by the investigator.
• People whose blood test results at screening show significantly abnormal liver function, bilirubin levels, kidney function markers, or a positive result for certain viruses including hepatitis B, hepatitis C, or HIV — though some exceptions may apply depending on follow-up test results (confirm with trial site).
• People who have a stiff ankle joint that cannot move, or who have had surgery that may affect foot strength measurements.
• People who have had orthopaedic surgery on their legs (such as bone correction, joint replacement, or arthroscopic surgery) within the 24 weeks before screening.
• People who have had a stroke or mini-stroke (TIA) within the 48 weeks before screening.
• People who have had a heart attack or unstable chest pain (angina) within the 48 weeks before screening.
• People who have had a cancer diagnosis within approximately the past 5 years (about 240 weeks), not including certain common skin cancers.
• People who have taken part in another clinical trial and received an investigational drug or device within 4 weeks before screening.
• People who have received immunosuppressant drugs, chemotherapy, or radiation therapy within 12 weeks before screening.
• People who have ever received cell therapy or gene therapy at any point in their life.
• People who have recently taken certain drugs known to damage peripheral nerves, including specific antibiotics, anti-inflammatory agents, antiretroviral drugs, or other named medications, within defined timeframes before screening (confirm with trial site for the full list and timeframes).
• People who are allergic or sensitive to any ingredient in the trial treatment.
• People who have metal implants in their body, such as a pacemaker, nerve stimulator, or cochlear implant.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
• People with a psychiatric condition such as an anxiety disorder or claustrophobia, or a history of drug or alcohol misuse, that may affect participation, as determined by the investigator.
• People who are considered unsuitable for any other reason, as determined by the investigator.

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