Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy (OPTIMUM)

March 31, 2025 updated by: Yuhan Corporation

Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial)

This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Gwangju, Korea, Republic of
        • Chosun University Hospital, School of Medicine, Chosun University
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of
        • Dongtan Sacred Heart Hospital, Hallym University College of Medicine
      • Incheon, Korea, Republic of
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Jeju, Korea, Republic of
        • Jeju National University College of Medicine
      • Jeollabuk-do, Korea, Republic of
        • Jeonbuk National University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center, University of Ulsan College of Medicine
      • Seoul, Korea, Republic of
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
      • Seoul, Korea, Republic of
        • Yeouido St. Mary's Hospital, The Catholic University of Korea
      • Seoul, Korea, Republic of
        • Seoul St.Mary's hospital, the Catholic university of Korea
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital, College of Medicine University of Ulsan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 19 to 75
  • type 2 diabetes mellitus with HbA1c (Hemoglobin A1c) ≤ 10 %
  • peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks)
  • diagnosed with diabetic peripheral neuropathy (DPN)
  • VAS pain score ≥ 40 mm
  • written informed consent

Exclusion Criteria:

  • brittle diabetes mellitus
  • ALT (Alanine Transaminase), AST (Aspartate Transaminase), CPK (Creatine Phosphokinase) level ≥ 3 times the upper limit of normal (UNL) or active liver disease
  • severe renal impairment (eGFR (estimated glomerular filtration rate) < 60 mL/min/ 1.73m2)
  • treated with antiepileptic drugs within 1 week at randomization
  • other nervous system or neuropathic disorders that may affect pain evaluation
  • oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients
  • pregnant, lactating, or childbearing potential
  • alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems
  • have participated in other clinical trials within 30 days at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin and alpha-lipoic acid combination therapy
Alpha-lipoic acid 480 mg/tablet once daily before breakfast and Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
Drug: Pregabalin 150mg + Alpha-lipoic acid 480mg
Pregabalin qd + alpha-lipoic acid qd
Experimental: Pregabalin monotherapy
Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
Drug: Pregabalin 150mg
pregabalin qd
Active Comparator: Alpha-lipoic acid monotherapy
Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.
Drug: Alpha-Lipoic Acid 480mg
alpha-lipoic acid qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analogue scale (VAS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
visual analogue scale (VAS)
Time Frame: 6 weeks
6 weeks
visual analogue scale (VAS) reduction rate of more than 30%
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks
visual analogue scale (VAS) reduction rate of more than 50%
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks
brief pain inventory Korean version, BPI-K
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks
total symptom score, TSS
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks
pain detect questionnaire, PD-Q
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks
3 level version of Euro-Qol-5 dimensions, EQ-5D-3L
Time Frame: 6 weeks, 12 weeks
6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Jongchul Won, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMC045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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