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

May 26, 2021 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Inje University Sanggye Paik Hospital
        • Contact:
          • JC Won

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

17 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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 (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 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)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

April 1, 2021

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

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.

Clinical Trials on Diabetic Peripheral Neuropathy

Clinical Trials on Pregabalin 150mg + Alpha-lipoic acid 480mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe