Evaluating Praga formulation for treating 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

This study is testing a new treatment called Praga to see if it can help people with nerve pain, especially those with diabetic polyneuropathy, feel better compared to other medications or a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: EMS (industry)
• Locations: 1 site (Campinas, São Paulo)
• Trial ID: NCT04666714 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of the Praga formulation in patients suffering from neuropathic pain, particularly those with diabetic polyneuropathy. Participants will be randomly assigned to receive either the Praga formulation, various doses of Pregabalin, or placebo treatments. The study will measure pain relief and safety outcomes over a specified period, utilizing standardized pain assessment scales to evaluate results. The trial is designed to provide robust data on the effectiveness of the Praga formulation compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of type 1 or type 2 diabetes and painful sensorimotor diabetic polyneuropathy.

Not a fit: Patients without a diagnosis of diabetic polyneuropathy or those with stable antidiabetic medication for less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients suffering from neuropathic pain, potentially improving their quality of life.

How similar studies have performed: Other studies have shown varying degrees of success with similar formulations for neuropathic pain, but this specific approach with Praga formulation is novel.

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.

Where this trial is running

Campinas, São Paulo

• Allegisa — Campinas, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Monalisa FB Oliveira, MD

Conditions: Neuropathic Pain