Lipoic Acid as a Treatment for Acute Optic Neuritis

Completed · Phase 1

Conditions studied: Optic Neuritis

In brief

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.

Key facts

Study ID

NCT01294176

Run by

Oregon Health and Science University

People needed

31

Starts

2011-01-01

Expected to finish

2016-11-01

Last updated by the study team

2019-04-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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