Clinical trial NCT04666714: Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neuropathic Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change from baseline in pain intensity.
timeFrame: 3 months
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
Study officials:
References: