Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Pregabalin

Criteria

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.