Thioctic acid (Alpha-lipoic acid) for Diabetic sensorimotor polyneuropathy

Inclusion criteria

• {"criterion_text":"- Written informed consent signed by the participants prior to any performance of trial-related screening procedures\n- Diagnosed mild to moderate symptomatic DSPN defined by abnormal or non-evocable sural nerve conduction velocity and/or abnormal or non-evocable sural nerve action potential AND DSPN symptoms (signified by NTSS-6 >6) AND neuropathic signs (signified by NDS of 3-8)\n- HbA1c ≤9.5 % at screening or at a time point between screening and randomization.\n- Willingness to avoid lifestyle changes or changes of diet during the trial (including start of drugs supporting weight loss)\n- Participants must have completed and documented their baseline symptom assessment over seven consecutive days and the NTSS-6 questionnaire on the final day of symptom assessment, using the provided ePRO link, in accordance with the protocol-defined schedule within the seven days prior to the randomization visit\n- Ability to follow trial restrictions\n- Ability to attend scheduled visits at the Investigator site for the duration of the trial.\n- Existence of a possibility to receive SMS\n- Male or female participants ≥18 years old at the time of screening\n- Diagnosed diabetes type 1 or 2 (per American Diabetes Association criteria (ADA Standards of Care in Diabetes 2025)), with diagnosis established at least 1 year prior to screening\n- Stable diabetes medication use (or stable insulin dose for insulin-dependent participants) in the last 3 months prior to screening, which is unlikely to be changed during the trial period, as judged by the investigator. In case of therapy with SGLT-2 inhibitors, the start of treatment must additionally be at least 26 weeks prior to screening\n- Stable diabetes metabolism, defined as no metabolic decompensation within the last 3 months (severe hypoglycaemia with unconsciousness, hyperosmolar hyperglycemic state, or ketoacidosis) prior to randomisation\n- Persistent or recurrent neuropathic symptoms (e.g., numbness, tingling, burning or stabbing pain, hypersensitivity) that have occurred at least within 3 months prior to randomization. These symptoms and their duration can be reported by the participant to the Investigator during anamnesis"}

Exclusion criteria

• {"criterion_text":"- Female participants with child-bearing potential not using any of the following effective birth control methods at least 2 months prior to randomization: a) oral contraceptives with a stable regimen; b) depomedroxyprogesterone; c) a double barrier method (either combining physical barrier methods e.g. condoms and diaphragm, or combining a physical barrier with a chemical barrier method, e.g. diaphragm/ condoms with spermicides); d) intrauterine device\n- Treatment with glucagon-like peptide-1 receptor agonists (GLP-RA) within the last 12 months prior to randomization\n- Any pharmacological treatment of chronic pain within the last 2 months prior to randomization. Exception is monotherapy with gabapentin up to 3000 mg/day, pregabalin up to 450 mg/day, or duloxetine up to 60 mg/day, without dose change within 2 months before randomization. For analgesia, standard doses of salicylates, ibuprofen or phenylacetic acid derivatives are allowed over a period of maximal 7 consecutive days, as well as rescue medication with paracetamol up to 3 g/day. Stable acetylsalicylic acid therapy in low doses for blood thinning purposes is also allowed\n- Any contraindication to the use of the trial medication, including known allergy/hypersensitivity\n- Significant hepatic disease (AST or ALT ≥3 times of upper limit of normal)\n- Significant renal disease (eGFR <30 ml/min/1.73m2)\n- Uncontrolled hypertension (systolic blood pressure >160 mm Hg, or diastolic blood pressure >100 mm Hg), with or without anti-hypertensive medication\n- A major cardiovascular event, such as myocardial infarction or stroke, or an acute malignant disease in the 12 months prior to randomization\n- Severe or unstable depression or severe or unstable other psychiatric diseases with potential influence on trial endpoints, as judged by the Investigator\n- Current treatment with antidepressants (except stable duloxetine or selective serotonin reuptake inhibitors)\n- Any other existing medical conditions, likely to affect the trial measures, as judged by the Investigator\n- Neuropathy of any cause other than diabetes (e.g. vitamin B12 deficiency-, chemotherapy-, toxin-, drug- or autoimmune-induced neuropathies, peripheral neuropathies induced by damages of the spinal cord), myopathy, or other neurological diseases that might interfere with trial endpoints\n- Currently active or history of alcohol abuse (defined as a regular intake of more than 24 units of alcohol per week for men and 12 units of alcohol per week for women; one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)\n- Current or history of regular use of recreational drugs (except history of occasional or experimental cannabis use in the past, with no evidence of dependence)\n- Participation in another interventional clinical trial within 2 months preceding randomization. Participation in registries is allowed\n- Living in the same household with another participant of this trial\n- Pregnant or nursing women at screening\n- Severe chronic pain of origin other than DPN which might interfere with the trial endpoints, based on medical history or physical examination (e.g. fibromyalgia).\n- Bilateral lower extremity amputations (above the ankle). Individuals with unilateral lower extremity amputation may be included, provided that the remaining limb allows for reliable assessment of neuropathy-related endpoints and safe participation in study procedures\n- History of a disease (including cardiovascular, pulmonary, gastrointestinal, hematologic, or endocrine disease, or malignancy) that could potentially cause neuropathic pain or symptoms\n- Maximum neuropathic pain level > 9 over the previous 4 weeks on a NRS as assessed at screening\n- Magnesium deficiency at screening which cannot be compensated until randomization\n- Treatment lasting 5 days or longer with concomitant medication containing ALA, BEN B-vitamins, evening primrose oil, deproteinized hemoderivates of calf blood, or other drugs or supplements with potential influence on trial endpoints (e.g. antioxidants) within the last 2 months prior to randomization\n- Treatment with cutaneous electrical nerve stimulation, muscle stimulation, or 8 % capsaicin patch within the last 2 months prior to randomization."}

Primary endpoints

• {"endpoint_text":"- Change from baseline measurement to day 112 in neuropathy symptom characteristics","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change from baseline measurement to day 28, day 56, and day 84 in neuropathy symptom characteristics","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline measurement to day 112 in neuropathy symptoms and neurological deficits","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in sural nerve conduction velocity and sural sensory nerve action potential amplitude from baseline measurement to day 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in the Neuropathy Disability Score (NDS) from baseline measurement to day 56 and day 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in the Neuropathy Total Symptom Score-6 from baseline measurement to day 27, 55, 83 and 111","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in maximum pain assessed by NRS (4 weeks) from baseline measurement to day 56 and day 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in Quality of Life from baseline measurement to day 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Effects on Patient Global Impression of Change score on days 56, 112, and 126","definition_or_measurement_approach":""}
• {"endpoint_text":"- Treatment emergent adverse events (TEAE)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Subjective tolerability by physician and participant, evaluated at day 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in vital signs (seated blood pressure and heart rate) from baseline measurement (day 0) to days 56 and 112","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in safety laboratory data (blood parameters) from screening to day 112","definition_or_measurement_approach":""}

Methods

• Recruitment responsibilities assigned to MedicalScan Kft. (listed as responsible for Recruitment in Hungary).

Hungary

Earliest CTIS Part Ii Submission Date

30-01-2026

Latest Decision Or Authorization Date

18-02-2026

Processing Time Days

19

Number Of Sites

10

Number Of Participants

136

Primary sponsor

Full Name

Woerwag Pharma GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Hungary","full_name":"Research Professionals Kft.","duties_or_roles":"codes: 1,11,12,2,3,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"IDV Data Analysis & Study Planning","duties_or_roles":"codes: 10,11","organisation_type":"SME"}
• {"country":"Germany","full_name":"Haupt Pharma Wuelfing GmbH","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"MedicalScan Kft.","duties_or_roles":"Recruitment","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Finland","full_name":"Mediracer Oy","duties_or_roles":"Nerve Conduction Study Device and Assessment Service","organisation_type":"Industry"}