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Completed

NCT Number: NCT04846673

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 150mg + Alpha-lipoic acid 480mg

Drug

Pregabalin qd + alpha-lipoic acid qd

Pregabalin 150mg

Drug

pregabalin qd

Alpha-Lipoic Acid 480mg

Drug

alpha-lipoic acid qd

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: 12 weeks

Secondary outcomes

  1. visual analogue scale (VAS)

    Time frame: 6 weeks

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

    Time frame: 6 weeks, 12 weeks

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

    Time frame: 6 weeks, 12 weeks

  4. brief pain inventory Korean version, BPI-K

    Time frame: 6 weeks, 12 weeks

  5. total symptom score, TSS

    Time frame: 6 weeks, 12 weeks

  6. pain detect questionnaire, PD-Q

    Time frame: 6 weeks, 12 weeks

  7. 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L

    Time frame: 6 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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)

Acronym: OPTIMUM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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