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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04846673
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 15.6
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	Drug: Pregabalin 150mg + Alpha-lipoic acid 480mg; Drug: Pregabalin 150mg; Drug: Alpha-Lipoic Acid 480mg	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 14, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. visual analogue scale (VAS) [12 weeks]

Secondary Outcome Measures

1. visual analogue scale (VAS) [6 weeks]

2. visual analogue scale (VAS) reduction rate of more than 30% [6 weeks, 12 weeks]

3. visual analogue scale (VAS) reduction rate of more than 50% [6 weeks, 12 weeks]

4. brief pain inventory Korean version, BPI-K [6 weeks, 12 weeks]

5. total symptom score, TSS [6 weeks, 12 weeks]

6. pain detect questionnaire, PD-Q [6 weeks, 12 weeks]

7. 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L [6 weeks, 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Sanggye Paik Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT04846673
• Other Study ID Numbers: YMC045
• First Posted: Apr 15, 2021
• Last Update Posted: Jun 1, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Thioctic Acid; Pregabalin

Study Results

No Results Posted as of Jun 1, 2021