Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia

NCT07712913 | Recruiting Phase 3

• 1 other identifier: HYP008-24
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 15

Brief Summary

Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia

Conditions

Diabetic Neuropathy; Neuropathic Pain; Neuralgia, Postherpetic

Keywords

multicenter; randomized; double-blind; double-dummy; controlled; parallel-group; non-inferiority; diabetic; postherpetic neuralgia; peripheral neuropathy; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline

  Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline, between the study drug and the comparator, as measured by the 11-point DPRS (Daily Pain Rating Scale) (ranging from 0 "no pain" to 10 "worst possible pain"). Participants completed the baseline scale at the research center and filled it out daily at home until visit V8, twice a day. The average number of scales will be calculated by dividing the number of scales completed by the number of days on which they were completed.

  16 weeks

Secondary Outcomes (5)

• To assess improvement in neuropathic pain during treatment.

  1 to 12 weeks

• To assess the proportion of participants who experienced significant improvement in neuropathic pain during and at the end of treatment.

  1 to 16 weeks

• To assess improvements in the impact of neuropathic pain on sleep, quality of life, and symptoms of anxiety and depression during and at the end of treatment.

  1 to 16 weeks

• Assess the participant's overall perception of change at the end of treatment.

  Week 16

• Evaluate the use of rescue medication.

  1 to 16 weeks.

Other Outcomes (1)

• Safety Outcome: To evaluate the safety of extended-release pregabalin tablets compared with immediate-release pregabalin tablets in participants with diabetic neuropathy or postherpetic neuralgia.

  19 weeks.

Study Arms (2)

Pregabalin XR: Extended-release pregabalin

EXPERIMENTAL

Pregabalin XR: will receive extended-release pregabalin tablets at an initial dose of 82.5 mg once daily (during the first week for titration). The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group may receive a placebo twice daily.

Drug: Experimental: Pregabalin XR; Drug: experimental placebo

Dorene Tabs: Immediate-release pregabalin

ACTIVE COMPARATOR

Dorene Tabs: will receive immediate-release pregabalin tablets (Dorene Tabs) at a starting dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparison group will receive a placebo once daily.

Drug: Comparator: Dorene Tabs; Drug: Comparator placebo

Interventions

Comparator placebo DRUG

Comparator placebo

Dorene Tabs: Immediate-release pregabalin

experimental placebo DRUG

experimental placebo

Pregabalin XR: Extended-release pregabalin

Comparator: Dorene Tabs DRUG

Pregabalin immediate-release tablets, at an initial dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparator group will receive a placebo once daily.

Dorene Tabs: Immediate-release pregabalin

Experimental: Pregabalin XR DRUG

Pregabalin XR: extended-release tablet, with an initial dose of 82.5 mg once daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group will receive a placebo twice daily.

Pregabalin XR: Extended-release pregabalin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 for at least 30 days.
• 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 screening/randomization visit, Participant Diary No. 1 containing the DPRS scales will be provided, in which the participant will record pain intensity daily upon waking and at the end of the day for 7 days (±2 days). The mean value for pain intensity recorded during the Screening/Randomization Phase will be used to confirm eligibility at the initial visit (IV).
• 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 of reproductive potential who agree to use a reliable method of contraception\*\*\*.
• 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 method. A safe contraceptive method is defined as the use of at least one of the following: condoms, a diaphragm, and/or a hormonal method (estrogenic and/or progestogenic) in the form of medication, including oral, vaginal, injectable, transdermal, and intrauterine devices. Only participants who expressly declare themselves exempt from the risk of pregnancy-whether because they do not engage in sexual activity or because they engage in it in a non-reproductive manner-will have the right to participate in the study without the mandatory use of contraceptives. Examples include participants who have undergone a vasectomy, those with an infertile partner, or those practicing total heterosexual abstinence.
• The decision regarding the best contraceptive method to use will be made jointly by the physician and the study participant. If there are any costs involved, the chosen contraceptive method will be provided by the sponsor free of charge for as long as necessary. In addition, condoms with spermicide will be provided to participants at all study visits, when applicable.

You may not qualify 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 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, memantine), antiepileptic drugs (e.g., carbamazepine, clonazepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin), antidepressants (e.g., tricyclics, serotonin reuptake inhibitors, venlafaxine), and potential neurotoxins (e.g., hydroxychloroquine, deferoxamine, thioridazine, vigabatrin).
• 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 hepatitis B, hepatitis C, or HIV.
• 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 men) in the past 2 years.
• \* A standard drink is: a can of regular beer (330 mL at 4%); a shot of distilled spirits (30 mL at 40%); a glass of wine or a small glass of sherry (100 mL at 12% or 70 mL at 18%); a small glass of liqueur or similar (50 mL at 25%) (53).
• 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.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (15)

Cpec Obras Sociais Irmã Dulce

Salvador, Estado de Bahia, 41680430, Brazil

RECRUITING

Instituto Anima de Extensão Universitária - Unibh

Belo Horizonte, Minas Gerais, 30575180, Brazil

RECRUITING

Centro de Ensino Superior de Vespasiano

Vespasiano, Minas Gerais, 33200664, Brazil

RECRUITING

Instituto Estadual Do Cerebro Paulo Niemeyer

Rio de Janeiro, Rio de Janeiro, 20231092, Brazil

RECRUITING

Apec Sociedade Potiguar de Educação E Cultura

Natal, Rio Grande do Norte, 59076000, Brazil

RECRUITING

Clinica Neurologica E Neurocirurgica de Joinville

Joinville, Santa Catarina, 89202190, Brazil

RECRUITING

Instituto Anima de Extensão Universitária - Unisul

Palhoça, Santa Catarina, 88137270, Brazil

RECRUITING

Fundação de Beneficência Hospital de Cirurgia

Aracaju, Sergipe, 49055480, Brazil

RECRUITING

Associação Aracajuana Hospital Santa Isabel

Aracaju, Sergipe, 49072720, Brazil

RECRUITING

Newdata Clinical Research

Aracaju, Sergipe, 49075000, Brazil

RECRUITING

Casa de Nossa Senhora Da Paz Ação Social Franciscana

Bragança Paulista, São Paulo, 12916900, Brazil

RECRUITING

Synvia Campinas

Campinas, São Paulo, 1308756, Brazil

RECRUITING

Trialstar Campinas

Campinas, São Paulo, 13092108, Brazil

RECRUITING

Synvia Clinical Barra Funda

São Paulo, São Paulo, 01139000, Brazil

RECRUITING

Iscp Sociedade Educacional

São Paulo, São Paulo, 03164000, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Neuralgia, Postherpetic; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariana Ferreira, Sports Nutrition

  A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana G. Augusto, Clinical Research Manager

CONTACT

55-11-97677-6726; juliana.augusto@brainfarma.ind.br

Juliana A. L. Antonio, Scientific Documentation Coord

CONTACT

juliana.antonio@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, double-blind, double-dummy, parallel-group study with two treatment groups

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 20, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

BR (15)