Lipoic Acid as a Treatment for Acute Optic Neuritis
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Thioctic acid
What it measured
Main measures
The primary outcome measure will be the difference from baseline in retinal nerve fiber layer (RNFL) thickness of the affected optic nerve, as determined by OCT, at 12 and 24weeks post LA treatment.
Baseline, Week 24
Retina scans (OCT)
Other measures (1)
Secondary outcome measures to assess optic nerve injury will be changes from baseline in the RNFL thickness at week 24, and changes from baseline in low- and high-contrast visual acuity, contrast sensitivity, and visual field changes at weeks 12 and 24.
Baseline, Week 24
Retina scans (OCT)Vision
Who could take part
Optic neuritis · 18 to 65
Inclusion Criteria: * Diagnosis of acute, unilateral AON with visual symptoms (vision loss) of 14 days or less * 18 - 65 years of age, inclusive * AON as a first event (possibly idiopathic) or in relationship to clinically isolated syndrome or to MS according to McDonald criteria * No previous history of optic neuritis or ophthalmoscopic signs of optic atrophy in the affected eye * Subject is available for treatment initiation within 14 days of onset of AON symptoms Exclusion Criteria: * Other causes of visual loss in the affected eye (e.g. amblyopia or glaucoma * OCT is non-evaluable at screening visit due to edema. * AON symptoms improve before administration of study medication. * Subject has fever or active infection at time of enrollment. * Subject is pregnant or breast-feeding. * Subject has diabetes mellitus. * Subject has another significant health problem (e.g. active coronary heart disease, liver disease, significant pulmonary disease).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system.
Papers
Loading reviews and guidelines…
History
Started
Jan 2011
Main results due
Nov 2016
Finished
Nov 2016
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