Normast 3 for adults with diabetic polyneuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial evaluating Normast 3 as an add-on to standard care for adults with diabetic polyneuropathy affecting small and large nerve fibers. Approximately 40 participants will be randomized 1:1 to receive Normast 3 or a matching placebo for 12 weeks, with assessments at baseline, end of treatment, and a 24-week follow-up. The study will measure changes in neuropathic pain and selected nerve function markers, including autonomic nervous system function, using clinical, psychophysical, and morphometric evaluations. Eligibility includes adults 18-80 with mixed-fiber diabetic polyneuropathy and stable prior treatments. Primary aim is to determine if Normast 3 reduces daily pain after 12 weeks compared with placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Diagnosis of mixed-fiber diabetic polyneuropathy Provision of signed and dated informed consent Willingness to comply with all study procedures and availability for the duration of the study Male or female participants aged 18 to 80 years Ability to take oral medication Stable pharmacological treatment during the 3 months before enrollment

Exclusion Criteria:

Concomitant peripheral or central nervous system disease that could interfere with the study objectives Conditions other than diabetes that could affect the peripheral nervous system, including vitamin B12 deficiency, kidney failure, previous neurotoxic therapies, thyroid disease, autoimmune diseases, or familial amyloidosis Cognitive impairment Major psychiatric comorbidities Inflammatory rheumatic diseases Pain due to conditions other than diabetic polyneuropathy Clinically significant disease or condition that could affect efficacy or safety assessments or otherwise preclude study participation, in the investigator's judgment Evidence or history of alcohol or drug abuse, including opioids, amphetamines, benzodiazepines, or cannabinoids Known or suspected unwillingness or inability to comply with the trial protocol or study instructions Inability to communicate meaningfully with trial site staff, including insufficient language skills Pregnancy or lactation Any other reason for exclusion according to the investigator's judgment

Where it's running

• Department of Human Neuroscience
  Rome, Italy, Italy Recruiting

Study contacts

• Principal investigator: andrea truini, full professor — department of human neuroscience, sapienza university
• Study coordinator: andrea truini, Full Professor
• Email: andrea.truini@uniroma1.it
• Phone: +39649914122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.