Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04666714

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

Led by EMS · Updated on 2025-03-14

136

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to confirm voluntary participation and sign informed consent forms
  • Adults aged 18 years and older
  • Diagnosis of type 1 or type 2 diabetes for at least 1 year
  • No change in antidiabetic medication within 3 months
  • Diagnosis of painful sensorimotor diabetic polyneuropathy
  • Presence of at least one symptom: numbness or paresthesias (tingling or neuropathic pain) in toes, feet, or legs
  • Presence of at least one sign: symmetrical reduced sensation or hypoactive/absent Achilles reflexes in distal legs
  • Glycated hemoglobin less than or equal to 11%
  • Score of 12 points or higher on the LANSS pain scale
  • Moderate to severe pain with a score of 4 or higher on the numerical pain scale (0-10)
  • Recorded moderate to severe neuropathic pain in diary for at least 4 of 7 baseline assessment days
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to any formula components used in the trial
  • History of alcohol or substance abuse in the past 2 years
  • Pregnant, breastfeeding, or planning pregnancy without reliable contraception
  • History of pernicious anemia, uncontrolled hypothyroidism, or chronic hepatitis B
  • HIV diagnosis
  • Neurological disorders unrelated to diabetic neuropathy
  • Non-response to previous pregabalin treatment
  • High variability in baseline pain scores
  • Conditions affecting sensitivity in neuropathic pain areas that may confuse pain assessment
  • Severe psychiatric conditions
  • Cognitive decline preventing proper questionnaire completion
  • Significant cardiac abnormalities posing risk for trial participation
  • Amputation of lower limb due to diabetes complications
  • Renal failure defined as estimated glomerular filtration rate below 60 mL/min/1.73 m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Allegisa

Campinas, São Paulo, Brazil, 13.084-791

Actively Recruiting

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Research Team

M

Monalisa FB Oliveira, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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