Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy

NCT06715462 | Withdrawn Phase 3 DMC

• 1 other identifier: EF188
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy (PDPN).

Conditions

Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes; Diabetes, Type 1; Diabetes, Type 2; Pain; diabetics; peripheral diabetic neuropathy; diabetic neuropathy peripheral; diabetic peripheral neuropathy; peripheral neuropathy; Peripheral Nervous System Diseases; peripheral; peripheral neuropathies; Peripheral nerve damage; neuropathies; neuropathy; PDPN

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain intensity in patients with painful diabetic peripheral neuropathy

  Change from baseline at the end of 12 weeks of treatment in the weekly average pain intensity in the last 24 hours using Numerical Rating Scale (11 points \[0-10\]), where higher scores mean a worse outcome.

  84 days

Secondary Outcomes (3)

• Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® in reducing pain in patients with painful diabetic peripheral neuropathy

  84 days

• Evaluation of the efficacy of N0750 compared to Cymbalta® and Lyrica® on subject perception of overall change in painful diabetic peripheral neuropathy

  84 days

• Evaluate the safety profile of N0750 compared to Cymbalta® and Lyrica®

  84 days

Study Arms (3)

N0750

EXPERIMENTAL

* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day

Drug: N0750

Cymbalta®

ACTIVE COMPARATOR

* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day

Drug: Cymbalta®

Lyrica®

ACTIVE COMPARATOR

* Phase 1 of the Dosage Titration: 3 capsules/day * Phase 2 of the Dosage Titration: 5 capsules/day * Treatment: 4 capsules/day * Withdrawal: 4 capsules/day

Drug: Lyrica®

Interventions

N0750 DRUG

N0750 caps + Cymbalta placebo caps + Lyrica placebo caps

N0750

Cymbalta® DRUG

Cymbalta® caps + N0750 placebo caps + Lyrica placebo caps

Cymbalta®

Lyrica® DRUG

Lyrica® caps + N0750 placebo caps + Cymbalta placebo caps

Lyrica®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to confirm voluntary participation and agree to all purposes of the trial, by signing and dating the Informed Consent Form (ICF) in two copies.
• Subjects of both sexes, aged between 18 and 80 years.
• Previous diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus.
• Subjects diagnosed with PDPN for at least 3 months, confirmed by NSS ≥ 5 points and NIS ≥ 3 points.
• Subjects who agree to discontinue current PDPN treatment during the washout period.
• Subjects willing and able to comply with all study requirements, including completion of study diary and questionnaires.

You may not qualify if:

• Painful peripheral neuropathy due to other causes, e.g. B12 and/or folate deficiency and hypothyroidism.
• Previous diagnosis of other types of pain not related to PDPN, which at the Investigator's discretion, may confound the assessment of clinical trial endpoints, such as, but not limited to: peripheral vascular disease (ischemic pain); neurological disorders unrelated to diabetic neuropathy (phantom pain due to limb amputation); other painful conditions (e.g., arthritis).
• Skin changes in the PDPN area that may cause changes in sensitivity or preclude physical assessment, e.g.: plantar ulcer.
• Subjects with any other clinically significant clinical or laboratory change that, at the opinion Investigator's opinion make the subject unsuitable for trial participation.
• Subjects with depression undergoing drug treatment or subjects with severe depression.
• Subjects with a history of angioedema.
• Subjects with a previous diagnosis of class III or IV heart failure according to the New York Heart Association criteria.
• History of seizures.
• Recent (\<6 months) myocardial infarction.
• Patients with increased intraocular pressure or who are at risk of closed-angle glaucoma.
• Subjects at risk of suicide at the Investigator's discretion.
• Prior treatment with chemotherapeutic agents that cause neuropathy, such as, but not limited to: platinum compounds (oxaliplatin, cisplatin and carboplatin) and taxanes (docetaxel and paclitaxel).
• History of current alcohol or drug abuse or dependence.
• Lack of response to prior treatment with pregabalin at doses ≥ 300 mg and/or duloxetine 60 mg.
• Use of prohibited medications within 7 days prior to the Screening Visit or change in concomitant drugs within 30 days prior to the Screening Visit.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratórios S.A

Itapevi, São Paulo, 06696-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Pain; Peripheral Nervous System Diseases; Neuritis

Interventions

Duloxetine Hydrochloride; Pregabalin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-02

Locations

BR (1)