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

Diabetic Peripheral Neuropathy Clinical Trial

— OPTIMUM  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846673
• Other study ID #: YMC045
• Status: Recruiting
• Phase: Phase 4
• Start date: May 14, 2021
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: Yuhan Corporation
• Contact: JC Won
• Phone: 82-2-950-8860
• Email: drwonjc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• Pregabalin 150mg + Alpha-lipoic acid 480mg
Pregabalin qd + alpha-lipoic acid qd
• Pregabalin 150mg
pregabalin qd
• Alpha-Lipoic Acid 480mg
alpha-lipoic acid qd

Locations

Country	Name	City	State
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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