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Also known as alpha-lipocic acid
Thioctic Acid · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Drug: Thioctic Acid | EXPERIMENTAL | 600mg tablet Thioctic Acid (alpha-lipoic acid) once daily throughout the trial |
| Drug: Placebo | PLACEBO_COMPARATOR | 1 tablet once daily throughout the trial |
| Name | Type | Description |
|---|---|---|
| Thioctic Acid | DRUG | - |
| Placebo | DRUG | 1 tablet once daily 4 years double-blind treatment period |
Inclusion Criteria: 1. Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year. 2. Patient must have a symmetric sensory-motor peripheral polyneuropathy of at least stage 2 attributable to diabetes mellitus following a thorough evaluation for other ca...
Thioctic acid is being developed for the treatment of diabetic polyneuropathy, a nerve condition that affects people with diabetes. Viatris Inc. is studying it as an oral treatment for symptomatic diabetic neuropathy and for diabetic polyneuropathy classified as Stage 1 or 2.
Viatris Inc. (ticker VTRS) is the developer of thioctic acid for diabetic polyneuropathy. The company is running the clinical program for this small molecule in the neurology therapeutic area.
Thioctic acid is in Phase 3 development for diabetic polyneuropathy. It is an investigational therapy and is not approved for this use. Two Phase 3 trials have been completed, and neither is currently active.
Thioctic acid has been studied in two completed Phase 3 trials. NCT00977483 assessed oral thioctic acid in diabetic polyneuropathy Stage 1 or 2 and enrolled 460 patients across the United States and Europe. NCT00328601, known as SYDNEY 2, enrolled 170 patients with symptomatic diabetic neuropathy in Israel and Russia.
Both Phase 3 trials of thioctic acid were randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older. Together they enrolled 630 patients with diabetic polyneuropathy. NCT00977483 enrolled 460 participants, and the SYDNEY 2 trial, NCT00328601, enrolled 170 participants.