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Completed

NCT Number: NCT01294176

Lipoic Acid as a Treatment for Acute Optic Neuritis

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.

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Key information

Conditions

Optic Neuritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Optic Nerve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

Oral lipoic acid is an antioxidant that helps proteins work in the body. It is available in oral and intravenous formulations and has been used in the past to treat nerve damage like that seen in diabetes and some other metabolic disorders. It is available as a dietary supplement in the United States.

Patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo medical and nervous system examinations, and blood draws. The study doctor will take a medical history and perform physical examinations. Research assistants at the MS Center, who are trained in blood draws, will perform the blood draws. Patients will also undergo Optical coherence tomography (OCT) examination at Casey Eye Institute, and receive two MRIs at Oregon Health and Science University (OHSU). Because it is a placebo-controlled trial, subjects will have a 50:50 chance of receiving either placebo (inactive) or study drug. If enrolled in the study, patients will take two gel capsules of the study drug or placebo at the same time every day for six weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

lipoic acid

Drug

Lipoic acid will be administered orally, in two 600mg capsules, for a total 1200mg dose. The dose will be administered daily for a 6-week treatment period.

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 24

    Individual data will be assessed at the last study visit (six months post baseline). Group data cannot be assessed until all participants have exited the study. The time frame for final assessment of the primary outcome measure is dependent on how quickly the recruitment goal is met.

Secondary outcomes

  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.

    Time frame: Baseline, Week 24

    Individual data will be assessed at the last study visit (six months post baseline). Group data cannot be assessed until all participants have exited the study. The time frame for final assessment of the primary outcome measure is dependent on how quickly the recruitment goal is met.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2011
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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