Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)

Summary

To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.

Timeline

Start

1998-05

Primary completion

2005-01

Completion

2005-01

Outcome

Missed primary endpoint

paper Change in primary end point from baseline to 4 years showed no significant difference between treatment groups (P = 0.105). PMID 21775755 ↗

paper Four-year treatment with ALA in mild-to-moderate DSPN did not influence the primary composite end point PMID 21775755 ↗

Publications

• Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schutte K, Dyck PJ. Efficacy and safety of antioxidant treatment with alpha-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thioctic Acid	Unknown	600 mg	Oral

Indications