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

NCT ID: NCT04666714

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Praga formulation

Intervention Type: DRUG

Praga formulation tablet

Placebo pregabalin 75mg

Intervention Type: OTHER

Placebo pregabalin 75mg tablet

Placebo Pregabalin 150mg

Intervention Type: OTHER

Placebo Pregabalin 150mg tablet

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

Group Type: ACTIVE_COMPARATOR

Pregabalin 75mg

Intervention Type: DRUG

Pregabalin 75mg tablet

Pregabalin 150mg

Intervention Type: DRUG

Pregabalin 150mg tablet

Placebo Praga formulation

Intervention Type: OTHER

Placebo Praga formulation tablet

Interventions

Praga formulation

Praga formulation tablet

Intervention Type: DRUG

Placebo pregabalin 75mg

Placebo pregabalin 75mg tablet

Intervention Type: OTHER

Placebo Pregabalin 150mg

Placebo Pregabalin 150mg tablet

Intervention Type: OTHER

Pregabalin 75mg

Pregabalin 75mg tablet

Intervention Type: DRUG

Pregabalin 150mg

Pregabalin 150mg tablet

Intervention Type: DRUG

Placebo Praga formulation

Placebo Praga formulation tablet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allegisa

Campinas, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Monalisa FB Oliveira, MD

Role: CONTACT

pesquisa.clinica@ncfarma.com.br

+551938879851

Other Identifiers

EMS1719 - PRAGA

Identifier Type: -

Identifier Source: org_study_id