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

Phase 4

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: Pregabalin 150mg + Alpha-lipoic acid 480mg; Drug: Pregabalin 150mg; Drug: Alpha-Lipoic Acid 480mg

• Registration Number: NCT04846673
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Study Start: 2021-05-14
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-06-01
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin and alpha-lipoic acid combination therapy	Pregabalin 150mg + Alpha-lipoic acid 480mg	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.
Pregabalin monotherapy	Pregabalin 150mg	Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
Alpha-lipoic acid monotherapy	Alpha-Lipoic Acid 480mg	Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS)	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of