NCT00977483

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

Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) NATHAN1 A Randomized, Placebo-controlled, Double-blind Multi-centre Trial With 2 Parallel Groups

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Stage 1 or 2a diabetic (poly)neuropathy (DNP) (Appendix 3) in patients with diabetes mellitus (type I or II); neuropathy impairment score of the lower limbs, enlarged by 7 objective items (NISLL+7) ≥ 97.5 percentile (corresponding to 4.43 score points); total symptoms score of the feet (TSSfeet) ≤ 5.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	Thioctic Acid	600mg tablet once daily 4 years double-blind treatment period
DRUG	Placebo	1 tablet once daily 4 years double-blind treatment period

Timeline

• Start date: 1998-05-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2009-09-15
• Last updated: 2022-02-07

Locations

38 sites across 9 countries: United States, Croatia, Denmark, France, Italy, Netherlands, Spain, Sweden, United Kingdom