Neuropathic PainPhase 3NCT04666714
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
A Phase 3 study testing Praga formulation, Pregabalin 75mg and Pregabalin 150mg in people with Neuropathic Pain, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Praga formulation, Pregabalin 75mg and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2023to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- Praga formulation, Placebo pregabalin 75mg, Placebo Pregabalin 150mg, Pregabalin 75mg, Pregabalin 150mg
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praga formulationDrug
Praga formulation tablet
Placebo pregabalin 75mgOther
Placebo pregabalin 75mg tablet
Placebo Pregabalin 150mgOther
Placebo Pregabalin 150mg tablet
Pregabalin 75mgDrug
Pregabalin 75mg tablet
Pregabalin 150mgDrug
Pregabalin 150mg tablet
Placebo Praga formulationOther
Placebo Praga formulation tablet
| Study group | Role | What they receive |
|---|---|---|
| Praga formulation | Experimental | 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 Receives: Drug: Praga formulation; Other: Placebo pregabalin 75mg; Other: Placebo Pregabalin 150mg |
| Pregabalin | Active comparator | 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 Receives: Drug: Pregabalin 75mg; Drug: Pregabalin 150mg; Other: Placebo Praga formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity.
The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary.
Measured: 3 months
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
The incidence and severity of adverse events recorded during the study will be determined over 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666714
- Sponsor's protocol ID
- EMS1719 - PRAGA
- Status last verified
- Mar 2025
- First submitted
- 8 Dec 2020
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666714
- Acronym / sponsor ID
- EMS1719 - PRAGA
- Conditions
- Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Praga formulation | Experimental | Drug: Praga formulation, Other: Placebo pregabalin 75mg, Other: Placebo Pregabalin 150mgThe 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 |
| Pregabalin | Active comparator | Drug: Pregabalin 75mg, Drug: Pregabalin 150mg, Other: Placebo Praga formulationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praga formulationPraga formulation tablet | Drug | Praga formulation |
| Placebo pregabalin 75mgPlacebo pregabalin 75mg tablet | Other | Praga formulation |
| Placebo Pregabalin 150mgPlacebo Pregabalin 150mg tablet | Other | Praga formulation |
| Pregabalin 75mgPregabalin 75mg tablet | Drug | Pregabalin |
| Pregabalin 150mgPregabalin 150mg tablet | Drug | Pregabalin |
| Placebo Praga formulationPlacebo Praga formulation tablet | Other | Pregabalin |
Primary outcome
Change from baseline in pain intensity.
Time frame: 3 months
The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary.
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Praga formulation, Pregabalin 75mg and Pregabalin 150mg in people with Neuropathic Pain, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monalisa FB Oliveira, MD (+551938879851, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.