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New treatment option for Diabetic Neuropathy
Official title Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
ClinicalTrials.gov ID: NCT07712913
What this study is testing
What is Experimental: Pregabalin XR?
Experimental: Pregabalin XR is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The following criteria must be met for a participant to be included in the study:
- Participants of either sex, aged 18 to 75 years.
- Be able to understand and agree to participate in the study, undergo the procedures, and attend the visits, as indicated by signing the informed...
- Have a diagnosis of peripheral neuropathic pain associated with:
- diabetes mellitus (type 1 or 2), with glycated hemoglobin (HbA1c) levels ≤ 11%, documented symptoms of peripheral diabetic neuropathy for at least 6...
You likely can't join if
- A positive response to any of the following criteria will exclude the participant from the study:
- The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the...
- Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the...
- Having undergone neurosurgical therapy for the treatment of neuropathy.
- Current use, or use within the past 7 days, of nerve block therapy and/or medications commonly used to treat neuropathic pain (e.g., benzodiazepines...
- History of treatment failure or hypersensitivity to pregabalin or gabapentin.
See the full eligibility criteria
- The following criteria must be met for a participant to be included in the study:
- Participants of either sex, aged 18 to 75 years.
- Be able to understand and agree to participate in the study, undergo the procedures, and attend the visits, as indicated by signing the informed consent form approved by the CEP/Conep System.
- Have a diagnosis of peripheral neuropathic pain associated with:
- diabetes mellitus (type 1 or 2), with glycated hemoglobin (HbA1c) levels ≤ 11%, documented symptoms of peripheral diabetic neuropathy for at least 6 months, and use of medication for glycemic control at a stable dose...
- postherpetic neuralgia, with pain symptoms for at least 3 months following a skin rash due to an acute episode of herpes zoster.
- Presence of neuropathic pain, with an intensity of ≥ 4 on the 11-point DPRS numerical scale (from 0 "no pain" to 10 "worst possible pain"‡). ‡ Pain intensity ≥ 4 will be confirmed at the initial visit (IV); during the...
- Participants who are unable to become pregnant (postmenopausal women, defined as 12 months or more of amenorrhea, or who have undergone surgical sterilization\ ; and men who have undergone vasectomy\ \ ) OR participants...
- Female sterilization (undergoing bilateral surgical oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to administration of the investigational drug.
- Male sterilization at least 6 months prior to screening. \ \ \ If the participant is of childbearing age and decides to participate in the study, they must use or request that their partner use a safe contraceptive...
- A positive response to any of the following criteria will exclude the participant from the study:
- The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the evaluation.
- Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the assessment.
- Having undergone neurosurgical therapy for the treatment of neuropathy.
- Current use, or use within the past 7 days, of nerve block therapy and/or medications commonly used to treat neuropathic pain (e.g., benzodiazepines, skeletal muscle relaxants, capsaicin, local anesthetics, opioids...
- History of treatment failure or hypersensitivity to pregabalin or gabapentin.
- History of neoplastic disease within the past 2 years (excluding basal cell carcinoma), neurological disease, unstable heart disease, psychiatric conditions (particularly suicidal ideation), and/or infection with...
- Current laboratory abnormalities in liver enzymes (elevated AST and/or ALT 2.5 times the upper limit of the reference range) and/or renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73 m²).
- History of illicit drug abuse in the past 2 years.
- History of alcoholism (average alcohol intake exceeding 3 standard drinks\ per day or more than 7 standard drinks per week for women, and exceeding 4 standard drinks per day or more than 14 standard drinks per week for...
- Being pregnant, breastfeeding, or intending to become pregnant during the study period.
- Having participated in clinical studies in the past 12 (twelve) months, unless there may be a direct benefit to the study participant, at the investigator's discretion.
- Having any condition that prevents participation, at the investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Vespasiano, Minas Gerais, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- Natal, Rio Grande do Norte, Brazil
- Joinville, Santa Catarina, Brazil
- Palhoça, Santa Catarina, Brazil
- Aracaju, Sergipe, Brazil
- Bragança Paulista, São Paulo, Brazil
- Campinas, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salvador, Estado de Bahia, Brazil; Belo Horizonte, Minas Gerais, Brazil; Vespasiano, Minas Gerais, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Natal, Rio Grande do Norte, Brazil; Joinville, Santa Catarina, Brazil and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.