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

NCT04846673 | Completed Phase 4

• 1 other identifier: YMC045
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• visual analogue scale (VAS)

  12 weeks

Secondary Outcomes (7)

• visual analogue scale (VAS)

  6 weeks

• visual analogue scale (VAS) reduction rate of more than 30%

  6 weeks, 12 weeks

• visual analogue scale (VAS) reduction rate of more than 50%

  6 weeks, 12 weeks

• brief pain inventory Korean version, BPI-K

  6 weeks, 12 weeks

• total symptom score, TSS

  6 weeks, 12 weeks

Study Arms (3)

Pregabalin and alpha-lipoic acid combination therapy

EXPERIMENTAL

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 monotherapy

EXPERIMENTAL

Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.

Drug: Pregabalin 150mg

Alpha-lipoic acid monotherapy

ACTIVE COMPARATOR

Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.

Drug: Alpha-Lipoic Acid 480mg

Interventions

Pregabalin 150mg + Alpha-lipoic acid 480mg DRUG

Pregabalin qd + alpha-lipoic acid qd

Pregabalin and alpha-lipoic acid combination therapy

Pregabalin 150mg DRUG

pregabalin qd

Pregabalin monotherapy

Alpha-Lipoic Acid 480mg DRUG

alpha-lipoic acid qd

Alpha-lipoic acid monotherapy

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (14)

Pusan National University Hospital

Busan, South Korea

Location

Chosun University Hospital, School of Medicine, Chosun University

Gwangju, South Korea

Location

Dongtan Sacred Heart Hospital, Hallym University College of Medicine

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

The Catholic University of Korea, Incheon ST. Mary's Hospital

Incheon, South Korea

Location

Jeju National University College of Medicine

Jeju City, South Korea

Location

Jeonbuk National University Hospital

Jeollabuk-do, South Korea

Location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul St.Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Yeouido St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Ulsan University Hospital, College of Medicine University of Ulsan

Ulsan, South Korea

Location

MeSH Terms

Interventions

Pregabalin; Thioctic Acid

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Jongchul Won

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: May 14, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

KR (14)