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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Praga formulation; Other: Placebo pregabalin 75mg; Other: Placebo Pregabalin 150mg; Drug: Pregabalin 75mg; Drug: Pregabalin 150mg; Other: Placebo Praga formulation

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Monalisa FB Oliveira, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13.084-791
      • Recruiting
      • Allegisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Praga formulation; 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; Praga formulation tablet; Other: Placebo pregabalin 75mg; Placebo pregabalin 75mg tablet; Other: Placebo Pregabalin 150mg; Placebo Pregabalin 150mg tablet
Active Comparator: Pregabalin; 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; Pregabalin 75mg tablet; Drug: Pregabalin 150mg; Pregabalin 150mg tablet; Other: Placebo Praga formulation; Placebo Praga formulation tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: EMS1719 - PRAGA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No