Status:
RECRUITING
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
Lead Sponsor:
EMS
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04666714
Start Date
May 15 2023
End Date
December 31 2025
Last Update
March 14 2025
Active Locations (1)
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1
Allegisa
Campinas, São Paulo, Brazil, 13.084-791