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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666714
• Other study ID #: EMS1719 - PRAGA
• Status: Recruiting
• Phase: Phase 3
• Start date: May 15, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa FB Oliveira, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Praga formulation
Praga formulation tablet

Other:
• Placebo pregabalin 75mg
Placebo pregabalin 75mg tablet
• Placebo Pregabalin 150mg
Placebo Pregabalin 150mg tablet

Drug:
• Pregabalin 75mg
Pregabalin 75mg tablet
• Pregabalin 150mg
Pregabalin 150mg tablet

Other:
• Placebo Praga formulation
Placebo Praga formulation tablet

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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