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

EMS

Status and phase: Enrolling; Phase 3

Conditions: Neuropathic Pain

Treatments: Drug: Pregabalin 75mg; Drug: Praga formulation; Other: Placebo Pregabalin 150mg; Drug: Pregabalin 150mg; Other: Placebo Praga formulation; Other: Placebo pregabalin 75mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04666714

EMS1719 - PRAGA

Details and patient eligibility

About

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

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups

Praga formulation

Experimental group

Description:

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

Treatment:

Other: Placebo pregabalin 75mg

Other: Placebo Pregabalin 150mg

Drug: Praga formulation

Pregabalin

Active Comparator group

Description:

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

Treatment:

Other: Placebo Praga formulation

Drug: Pregabalin 150mg

Drug: Pregabalin 75mg