Trials Sponsors Conditions Drugs Pricing

Conditions

Polyneuropathy, Diabetic

Keywords

ThiotacidDouble-blindedPlacebo-controlledMulti-center

Outcome Measures

Primary Outcomes (1)

To compare the relative change in NCS parameters between the study arms
The main objective of this study is to calculate the efficacy of alpha-lipoic acid in comparison with placebo in diabetic patients with symptomatic polyneuropathy assessed by the change in NCS parameters after 4 weeks of treatment using student t-test (Mann-Whitney test for non-parametric data) to compare relative change between treatment arm and control arm. This analysis will be comparative and will be done on eligible subjects without protocol violation and who have at least one treatment dose and an evaluable primary endpoint.
After four weeks of treatment

Secondary Outcomes (4)

To compare the relative change in NCS parameters between the study arms.
After 24 weeks of treatment
To compare the relative change in NDS and Neuro-QoL between the study arms.
After 24 weeks of treatment
To compare the frequency of the need to rescue analgesic medications between the study arms
After 24 weeks of treatment
To assess safety of Thiotacid® as per the nature and severity of the recorded adverse events.
After 24 weeks of treatment

Study Arms (2)

IND Arm

EXPERIMENTAL

200 patients will receive one tablet of 600 mg of alpha-lipoic acid twice a day orally for 24 weeks.

Drug: Alpha-Lipoic Acid (ALA)

Placebo Arm

PLACEBO COMPARATOR

200 patients will receive one tablet of placebo twice a day orally for 24 weeks.

Drug: Placebo

Interventions

Alpha-Lipoic Acid (ALA)Drug

Oral tablet

Also known as: Thiotacid® 600 mg

IND Arm

PlaceboDrug

Microcrystalline cellulose (Ph 101) 427.5 mg, Magnesium stearate 71.25 mg, Sodium laurayl sulphate 6 mg, Croscarmellose sodium 11.25 mg, Silica, colloid anhydrous 11.25 mg, and Purified talc 30 mg.

Also known as:

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Signed informed consent form.
Male or female patients aged ≥ 18 and ≤ 64 years.

Sponsors & Collaborators

MARC-CRO
Type not reportedcollaborator
Eva Pharma
Industrylead

Study Sites (5)

Alexandria University

Alexandria, Bab Sharqi, 21544, Egypt

Beni Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 2711860, Egypt

Ain-Shams University Hospital

Cairo, Heliopolis, 11588, Egypt

Menoufia University Hospital

Shibīn al Kawm, Shebin El Kom, Egypt

Mansoura University Hospital

Al Mansurah, Egypt

Related Publications (7)

ADA. (2022). Standards of Medical Care in Diabetes-2022 Th E Jou R Nal of C Li N Ical an D Appli Ed R Esearc H an D Education. Diabetes Care, 45(Suppliment 1), S1-S264. https://doi.org/10.2337/dc22-SREV
BACKGROUND
Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.
PMID: 15793206BACKGROUND
Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PMID: 27999003

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Thioctic AcidTablets

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur Compounds

Study Officials

Samir H Assaad Khali, PhD
Alexandria University Hospital / Internal Medicine
PRINCIPAL INVESTIGATOR
Mohamed R Halawa, PhD
Ain-Shams University Hospital / Internal Medicine
PRINCIPAL INVESTIGATOR
Nabil AF El Kafrawy, PhD
Menoufia University Hospital / Internal Medicine
PRINCIPAL INVESTIGATOR
Hanan M El Sotouhy Gawish, PhD
Mansoura University Hospital / Internal Medicine
PRINCIPAL INVESTIGATOR

Enrollment

430 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double-blinded
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

You may not qualify if:

Female patients with child-bearing potential not using effective birth control methods including oral contraceptives with a stable regimen for at least 2 months, depo-medroxyprogesterone, a barrier method alone (diaphragm, condoms, or contraceptive sponge with spermicidals), or an intrauterine device that has been in place for at least 2 months.
Patients with neuropathies other than DSPN; myopathy and other neurologic diseases that might interfere with the assessment of the severity of DSPN.
Patients with a recent history of drug or alcohol abuse; within 1 year prior to study entry.
Patients with a history of peripheral vascular disease and/or foot ulcers.
Patients with a history of organ transplantation.
Patients with a history of cardiovascular, pulmonary, gastrointestinal, hematologic, or endocrine disease, or malignancy that cause neuropathic pain.
Hospitalization due to hypoglycemia or ketoacidosis within 3 months prior to study entry.
Patients with significant hepatic or renal disease \[Serum creatinine \> 1.8 mg/dL for men and \> 1.6 mg/dL for women, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times upper limit of normal (ULN)\].
Use of medications indicated for neuropathic pain relief within 15 days (washout period) prior to study entry. For analgesia, standard doses of salicylates, ibuprofen, indoles, fenamates, oxicams, or pyrazoles are allowed.
Use of antioxidants (including but not limited to vitamin E, vitamin C, and β-carotene) or pentoxifylline within 1 month prior to study entry.
Use of medications or vitamins known to cause peripheral neuropathy including but not limited to the use of phenytoin or carbamazepine over 15 or more years, or use of pyridoxine \> 100 mg/d within 12 months prior to study entry.
Use of ≥ 50 mg ALA or use of alpha-linolenic acid-containing substances within 3 months prior to study entry.
Use of an investigational drug within 6 months prior to study entry.
Enrollment in any other clinical trial during the time of this trial.

Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

IND Arm

Placebo Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

IND Arm

Placebo Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations