Lipoic Acid as a Treatment for Acute Optic Neuritis

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Antioxidants; Thioctic Acid

Criteria

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).