National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain

EMS1719 - PRAGA

The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.

2023-05-15

2024-12-01

2025-08-01

Recruiting

Early phase I

136

Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Participants of 18 years and older; * Diagnosis of type 2 or type 1 diabetes for at least 1 year; * No change in antidiabetic medication winthin 3 months; * Diagnosis of painful sensorimotor diabetic polyneuropathy; * Presence of at least one of the following symptoms: i. numbness in the toes, feet and / or legs; ii. paresthesias (tingling and / or neuropathic pain) in the toes, feet and / or legs. * Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes; * Glycated hemoglobin ≤ 11%; * Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points); * Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score. Exclusion Criteria: * Known hypersensitivity to the formula components used during the clinical trial; * History of alcohol and/or substance abuse within 2 years; * Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception; * History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B; * HIV diagnosis; * History of neurological disorder unrelated to diabetic neuropathy; * Non-responders to previous pregabalin treatment; * High variability in the baseline pain score; * Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment; * Severe psychiatric condition; * Cognitive decline that affect the participant from correctly answering the scales and questionnaires; * Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial; * Participant who has amputated lower limb due to complications from diabetes; * Renal failure, defined by the estimated glomerular filtration rate \[eGFR\] \<60 mL / min / 1.73 m2.

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2024-02-16