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

NCT04666714 | Recruiting Phase 3 DMC

• 1 other identifier: EMS1719 - PRAGA
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  6 months

Study Arms (2)

Praga formulation

EXPERIMENTAL

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; Other: Placebo pregabalin 75mg; Other: Placebo Pregabalin 150mg

Pregabalin

ACTIVE COMPARATOR

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; Drug: Pregabalin 150mg; Other: Placebo Praga formulation

Interventions

Praga formulation DRUG

Praga formulation tablet

Praga formulation

Placebo pregabalin 75mg OTHER

Placebo pregabalin 75mg tablet

Praga formulation

Placebo Pregabalin 150mg OTHER

Placebo Pregabalin 150mg tablet

Praga formulation

Pregabalin 75mg DRUG

Pregabalin 75mg tablet

Pregabalin

Pregabalin 150mg DRUG

Pregabalin 150mg tablet

Pregabalin

Placebo Praga formulation OTHER

Placebo Praga formulation tablet

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Monalisa FB Oliveira, MD

CONTACT

+551938879851; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: May 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)