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

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

Official Title
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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

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Praga formulation
* Other: Placebo pregabalin 75mg
* Other: Placebo Pregabalin 150mg
* Drug: Pregabalin 75mg
* Drug: Pregabalin 150mg
* Other: Placebo Praga formulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Praga formulation<br>The study is double-dummy. The participant must take pills twice a day, as follows: Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral | Drug: Praga formulation<br>* Praga formulation tablet<br>Other: Placebo pregabalin 75mg<br>* Placebo pregabalin 75mg tablet<br>Other: Placebo Pregabalin 150mg<br>* Placebo Pregabalin 150mg tablet<br>|
| Active Comparator: Pregabalin<br>The study is double-dummy. The participant must take pills twice a day, as follows: Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral | Drug: Pregabalin 75mg<br>* Pregabalin 75mg tablet<br>Drug: Pregabalin 150mg<br>* Pregabalin 150mg tablet<br>Other: Placebo Praga formulation<br>* Placebo Praga formulation tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain intensity. | The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. | The incidence and severity of adverse events recorded during the study will be determined over 6 months. | 6 months |